943 Product Quality jobs in the United Kingdom

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra ® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Product Quality Engineer oversees device inspection and acceptance activities for the OrganOx Metra, a Class III medical device. These activities include but are not limited to oversight of incoming inspection, nonconforming material and material review board, calibration and measurement systems, and product acceptance. This position works closely with contracted manufacturers and quality inspectors to ensure day to day execution of these critical business processes and lead improvements of these processes.

This position involves supervisory responsibilities of Quality Inspectors and technicians, as well as executing continuous improvement initiatives to improve product quality. This is an onsite position.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the Sr. Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for:

• Leadership and Team Development
• Day to day management of quality inspectors and technicians
• Define team goals in collaboration with the Sr. Manager, Product Quality Engineering
• Manage performance reviews and development plans for quality inspectors and technicians
• Day to Day management and monitoring of KPIs related to product quality (Ex- Investigation Aging, NC aging and resolution)
• Promote a culture of accountability, collaboration and continuous improvement.

• Technical Quality Engineering Oversight

• Conducting hands on oversite of the device acceptance process, ensuring device acceptance targets are met.
• Conducting hands on oversight of the incoming inspection process, ensuring inspection targets are met.
• Conduct root cause investigations regarding non-conforming product
• Lead and support continuous process improvements related to device acceptance and incoming inspection
• Leading Material Review Board and dispositioning inspected product
• Execution of non-conformances
• Trending and analysis of non-conformance data to drive decisions
• Support updates to specification templates and inspection criteria 
• Support development of inspection fixtures and tooling
• Ensure calibration records are up to date
• Lead and support quality process improvements, identify systemic issues and drive continuous improvement initiatives

• Regulatory Compliance & QMS

• Ensure adherence to regulatory standards: FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP, etc.
• Support regulatory submissions, internal audits, and external inspections (e.g., FDA, Notified Body).
• Maintain and improve quality processes and documentation within the QMS.
• Cross-Functional Collaboration
• Participate in Design Reviews and Change Control Boards.
• Collaborate with suppliers and contract manufacturers on quality standards, audits, and issue resolution.
• Communicate diligently with evidence-based communication to management and peers

•  Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Requirements

Skills & Experience

• Proven related quality engineering work experience within the medical device field or other highly regulated industry required
• Knowledge of regulatory and quality standards: FDA QSR, ISO 13485, ISO 14971, EU MDR. 
• Ability to travel internationally up to 30% to support contract manufacturers and suppliers, visit OrganOx sites, and visit customer sites
• Demonstrable technical quality engineering skills including root cause analysis, test method development, fixture development, and project management
• Experience working with nonconformances, CAPAs and SCARs
• Proven track record of problem solving and improving quality processes
• Experience with statistics and data analysis

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field required
• ASQ Certifications (CQE, CMQ/OE, CQA) preferred 
• Six Sigma Green Belt or Black Belt Certification preferred

Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.

Product Quality Engineer – Medical Devices

Location: Kidlington

Salary: Highly Negotiable, Dependent on Experience

An exciting opportunity to join a growing medical imaging company developing cutting-edge 3D imaging technology. With commercialisation underway in the UK and US, we are expanding our manufacturing capability and seeking a Product Quality Engineer to strengthen the Quality & Regulatory Affairs team.

Role Overview

The Product Quality Engineer will plan, coordinate, and manage quality assurance and quality control activities across product development, manufacturing, and post-market. This includes developing DHF deliverables, supporting verification/validation, managing non-conformances and CAPAs, and providing compliance guidance to colleagues. The role plays a key part in ensuring adherence to ISO 13485, FDA 21 CFR 820 (transitioning to QMSR), and CE/510k requirements.

Key Responsibilities

• Lead and support quality engineering activities for medical, veterinary, and non-destructive testing systems.
• Contribute to design and manufacturing documentation, ensuring products can be effectively manufactured and tested.
• Oversee risk management planning, assessment, and reporting for new and modified products.
• Support design transfer, supplier qualification, and quality test method validation.
• Generate and maintain quality documentation, including SOPs, work instructions, and inspection procedures.
• Manage NCRs, CAPAs, and continuous improvement initiatives.
• Collaborate with R&D, suppliers, and manufacturing teams to embed quality throughout the lifecycle.
• Provide training and guidance on regulatory compliance and quality standards.

Qualifications & Skills

• Degree in Science or Engineering, or equivalent experience.
• Recognised Quality Management System qualification (e.g., ISO auditor) or similar experience.
• Strong knowledge of product development, manufacturing, and quality systems in regulated industries, ideally medical devices.
• Familiarity with standards such as ISO 13485, FDA QSR, risk management (FMEA), and medical device cybersecurity.
• Skilled in Lean/Six Sigma methods and tools such as Minitab, DOE, and SPC.
• Excellent planning, problem-solving, and communication skills, with the ability to work independently and collaboratively.

This is a great opportunity to join an innovative scale-up and directly contribute to the delivery of high-quality, safe, and effective products to market.

Final Garment Examiner
Full Time | 3 Month Contract
£24,761 Per Annum
Be part of 240 years of British knitwear excellence

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At John Smedley , weve been crafting the worlds finest knitwear for over two centuries and our commitment to excellence begins and ends with quality. Were looking for a Final Garment Examiner to join our Finish.

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ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra ® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Product Quality Engineering team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the OrganOx Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes.

The Product Quality Engineer will have strong technical skills with an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality.

The successful candidate is collaborative, has excellent communication and problem-solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

This is an on-site role in Oxford, with flexibility.

Major Responsibilities

Under direction from the Senior Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following:

• Analyze and trend on product performance data to provide recommendations for product improvements
• Raise Supplier Corrective Action Reports (SCARs) and Nonconforming Material Reports (NCs) in response to product performance trends
• Support root cause investigation and timely closure of SCARs and NCs
• Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures.
• Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
• Supports updates to supplier quality agreements
• Support validation of new processes at suppliers
• Support hands-on analyses of returned products to identify root causes of failures

• Support development of investigation criteria and test methods to properly diagnose and root cause field failures  
• Provide technical insight to sterilization and microbiological processes
• Support CAPAs, Escalations, and engineering investigations in response to product quality issues.

• Participate in the development and review of engineering change orders that impact product quality activities
• Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Requirements

Skills & Experience

• Demonstrable related hands on engineering experience in the medical device industry, or equivalent.
• Knowledge of medical device sterilization and microbiology preferred 
• Excellent technical report writing skills
• Strong Root Cause Analysis, Design Of Experiments, and test method development  experience as related to complaint investigations
• Experience investigating and resolving SCARS and CAPAs 
• A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.
• Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
• Strong experience with statistical analysis of data. Experience with Minitab preferred.
• Experience with Six Sigma principles preferred.
• Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills
• A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.
• Strong focus on meeting customer needs.
• Proven ability to work cross functional and within global teams, fostering a culture of high collaboration.   
• Ability to be self driven and solve complex problems independently. Committed to upholding OrganOx values in daily work and decision-making.
• Experience in driving a global quality mindset across teams and geographies.
• Demonstrated strong attention to detail and “do it right the first time” attitude

Qualifications

• Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience
• Ability to travel 10-20%
• Familiarity with ISO14971 and associated Risk Management Processes is a plus
• Six Sigma Green Belt or Black Belt Certification preferred

Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.

• Oversee the Global Reliability and Failure Analysis function to implement quality systems, guidelines, plans and policies to effectively ensure the highest quality and reliability of the company’s products.
• Support key customer issues to achieve quality standards, systems and objectives utilizing appropriate procedures and cost savings methods.
• Participate in the reviewing of engineering designs with R&D and Engineering group to contribute quality and reliability requirements and considerations. This includes working with R&D design team to assess reliability and burn-in for new technology platforms and new products
• Direct the assistance of product support areas in gathering and analyzing data.
• Select and manage appropriate global subordinate reliability and FA management group to ensure smooth coverage of quality and reliability functions.
• Represent MOSFET division in industry community such as JEDEC and AECQ
• Continue building internal Reliability and FA best-in-class standard and practice with respect to new materials or new technologies
• Design and drive the enablement of world-class Quality and Reliability requirements for wide-bandgap (SiC) power product release to the market, that meet both industry standards (JEDEC and AEC) and customer requirements
• Establish the industry best-in-class methodology to test and to characterize SiC power semiconductor devices to understand their reliability and failure mechanisms during R&D, Transfer (New Product Introduction or NPI) and High-Volume-Manufacturing (HVM).
• Design experiments and co-ordinate statistical studies to determine device reliability, for example gate oxide lifetime marathon test, time-dependent dielectric breakdown.
• Lead and collaborate with R&D, Engineering and Operation in establishing screening and burn-in procedures for SiC power devices to meet product quality requirements, to comply to industry requirement (JEDEC and AEC) and to meet specifics customer requirements (e.g. Board Level Reliability) during R&D, NPI and HVM.
• Lead and contribute to R&D, NPI and HVM quality/reliability projects, presenting results to senior management / external stakeholders (including non-technical staff).
• Design the requirements for quality and reliability test equipment, coordinate their development and enable transfer to manufacturing when needed
• Collaborate closely with both internal and external stakeholders, including R&D, Engineering, Marketing, and academic collaborators.
• Represent the company in the industry council such as JEDEC or AECQ.
  

• A PhD or Masters-level degree in electronics engineering, physics or any other microelectronics-related field.
• 15+ years of experience in quality and reliability with significant experience at top organizational level of semiconductor industry. Familiarity with reliability and failure modes of power semiconductor discrete devices, power ICs and SiC.
• 5+ years of experience in the field of wide-bandgap power semiconductor technology (ideally SiC).
• Experience leading global team in reliability testing of SiC MOSFETs and diodes, both at wafer- and package-level; preferred to have GaN experiences as well.
• A good understanding of statistical analysis and design of experiments.
• Knowledge of semiconductor TCAD tools for device simulation, i.e. Synopsys Sentaurus, Silvaco Victory;
• Excellent leadership and problem-solving skills – able to identify problems and/or opportunities for improvement and assesses viable solutions. Develop and execute comprehensive action plans.
• Ability to effectively manage multiple assignments concurrently, including ability to assess and manage priorities.
• Effective communications skills, particularly the ability to communicate technical expertise.
• Excellent interpersonal and teamwork skills. Must be able to build rapport with Operations and cross-functional colleagues and be able to foster collaborative relationships.
• You will have a comprehensive, demonstrable background in power semiconductors / semiconductor physics and/or electronics engineering. You will approach tasks in a logic-based way, along with having the ability and motivation to develop novel and creative ideas. Your communication skills will enable seamless collaboration both with our manufacturing partners and internally, and you will know how to build and maintain lasting relationships in international and cross-functional project teams.
  

Role:
Product Complaints Quality Manager

Company Name:
Vertex Pharmaceuticals

Type of Role:
Contract position, Inside IR35

Contract Length:
12 months

Location:
Hybrid, 3 days on site in Paddington, London, UK

Department:
Operational Area Quality

Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

General Summary:

The Quality Product Complaints Manager is responsible for providing quality oversight of the Product Complaint Quality System and Global Recall and Defect Notification Systems.

This role will support quality activities associated within the CMC Compliance team and will partner with various internal and external cross-functional teams including Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centers.

Key Duties and Responsibilities:

• Support activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.
• Process incoming clinical and commercial product complaints, including intake, initial evaluation and triage.
• Conduct product complaint investigations and author investigation reports.
• Coordinate with CMOs as needed for external investigations.
• Perform Quality review of complaint investigations owned/authored by other members of the team.
• Escalate critical issues to senior management.
• Oversees all activities associated with the global recall and defect notification processes, including mock recalls, SOP management, evaluation of regulatory intelligence and health of the systems.
• Leads product complaint investigations, coordinates with CMOs for external investigations, performs Root Cause Analysis, identifies Corrective Actions and escalates critical issues to senior management.
• Develops quarterly product complaint trend reports, initiates trend investigations and evaluates metrics/KPIs to assess quality impact and adverse trends.
• Coordinates activities associated with Counterfeit/Suspect product investigations and evaluates third-party investigation reports for potential threats / required escalation.
• Contributes to quarterly Quality Management Review (QMR) meetings for Product Complaints.
• Supports global regulatory inspections and inspection readiness activities

Knowledge and Skills:

• Strong understanding of industry standards and best practices.
• Proven ability to collaborate with cross-functional teams.
• Proven ability to manage projects of significant scope and complexity, while meeting deliverables and timelines.
• Strong strategic, critical and analytical thinking skills.
• Strong technical writing, presentation and communication skills.
• Experience in Medical Devices and Combination Products an advantage
• Bachelor's degree in a scientific or allied health field.

Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.

Moog is a performance culture that empowers people to achieve great things. Our people enjoy solving interesting technical challenges in a culture where everyone trusts each other to do the right thing. For you, working with us can mean deeper job satisfaction, better rewards, and a great quality of life inside and outside of work.

Job Title:

Product and Quality Engineering Internship

Work Schedule:

Onsite – Tewkesbury, GBR

Job Description

Moog design, manufacture and test micro-hydraulic components and systems for a range of industries and apply our global product range to provide bespoke customer solutions to solve difficult motion control problems. Typical Moog Industrial applications include:

Motorsport, F1 & Automotive

Power generation

Industrial motion control

Simulation & Test solutions

Oil & Gas

• Enjoy the challenge of creating things that the rest of the world only dream about
• Moog culture is fundamentally about respect and trust

We are continually developing our products and processes and as a result we have created an opportunity for an aspiring student to undertake a 12-month placement with us and continue the support provided by our existing 2024 intern.

We currently have the following opportunity:

Product Engineering Internship

This is an opportunity to develop your engineering skills and invest in your professional development whilst working within a highly skilled and dynamic engineering team.

The role covers a broad range of abilities but is primarily focused on the productionisation and development of assemblies and components. You will be involved in a wide variety of projects, likely focusing on micro hydraulics products and processes, supporting manufacturing, assembly, testing and new product development. You will be working alongside our Engineering team, Operations team and Assembly and Test team, reviewing current manufacturing, assembly and test processes and procedures and reporting your findings.

You will be keen to work and develop in areas such as product development, engineering analysis, process development and CAD but above all you will be a hands-on individual.

Experience/Qualifications required:

Currently Studying (2nd / 3rd years or recent Graduates) an Engineering related degree

Demonstrable experience in practical problem solving and workshop skills, either in University projects or in your own outside interests

Individuals with skill sets including electrical design, mechanical design, product development, design for assembly, lean activities, programming, machining, control theory, and hydraulics are highly valued and would be seen as an asset for the placement

About you:

Interest in developing a technical career within engineering

Ability to interact at all levels of a business, with excellent written and verbal communication skills, whilst being a sociable and interactive team member

Team player, self-motivated, methodical in approach, quick to learn and able to work under pressure to tight timescales

In Return Moog can offer you:

You'll have access to career progression opportunities and learning and development programs that will empower you to grow both personally and professionally.

Enjoy a comprehensive Flexible Benefits Package, 33 Days Annual Leave (including Bank Holidays), Private Medical Insurance, access to mental health support and expert financial advice. You'll also benefit from free parking, Life Assurance, a Company Pension Contribution starting at 6%, Employee Share Options.

You Matter at Moog – Our Mission and Vision

At Moog, we prioritize diversity, equity, and inclusion. We aim to create a culture where everyone is valued, respected, and given equal opportunities. We strive to empower employees to bring their authentic selves to work, celebrating our differences to foster a welcoming environment for all.

Embrace the journey and explore exciting possibilities

Note for Recruitment Agencies: We manage vacancies internally, preferring direct hiring and referrals for efficiency. When needed, we engage agencies from our Preferred Supplier List (PSL). Speculative CVs from agencies not on our PSL will not be considered, and no introduction fee will apply.