Senior Product Quality Engineer - United Kingdom - OrganOx

Description

Senior Product Quality Engineer - Retained Unit3 days ago Be among the first 25 applicants

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 Senior Product Quality Engineer develops and oversees product and device inspection and acceptance activities for the OrganOx Metra, a Class III medical device. Responsibilities include first article inspection processes, oversight of incoming inspection, non‐conforming material management, material review board, and product acceptance. The role works closely with contracted manufacturers, suppliers, and quality inspectors to ensure day‐to‐day execution of these critical business processes and leads improvements of these processes. It involves supervisory responsibilities of Quality Inspectors and Technicians and the execution of continuous improvement initiatives to improve product quality. This is an onsite position in Oxford with flexibility.

Major Responsibilities

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 (e.g., Investigation Aging, NC aging and resolution)

Promote a culture of accountability, collaboration and continuous improvement.

Technical Quality Engineering Oversight

Hands‐on oversight of the device acceptance process, ensuring device acceptance targets are met.

Hands‐on oversight of the incoming inspection process, ensuring inspection targets are met.

Development of first article inspection processes

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.

RequirementsSkills & Experience

Significant related quality engineering work experience within the medical device field or other highly regulated industry.

Knowledge of regulatory and quality standards: FDA QSR, ISO 13485, ISO 14971, EU MDR.

Demonstrable technical quality engineering skills including root cause analysis, test method development, fixture development, and project management.

Experience working with non‐conformances, first article inspections, CAPAs and SCARs.

Proven track record of problem solving and improving quality processes.

Experience using statistics and data analysis to solve quality problems.

Ability to travel internationally up to 30% to support contract manufacturers and suppliers, visit OrganOx sites, and visit customer sites.

Qualifications

Bachelor's degree in Engineering, Life Sciences, or a related technical field.

ASQ Certifications (CQE, CMQ/OE, CQA) preferred.

Six Sigma Green Belt or Black Belt Certification preferred.

BenefitsAt 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.

#J-18808-Ljbffr