Product Quality Engineer

OverviewOrganOx 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 OrganOx metra normothermic machine perfusion (NMP) system for liver transplantation has been used to support more than 5,000 liver transplant operations globally.

Position SummaryThe 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, incoming inspection, nonconforming material and material review board, calibration and measurement systems, and product acceptance. This role works closely with contract manufacturers and quality inspectors to ensure day-to-day execution of these critical processes and leads improvements of these processes. This is an onsite position with supervisory responsibilities over Quality Inspectors and Technicians and involves executing continuous improvement initiatives to enhance product quality.

Major Responsibilities

Under direction from the Sr. Manager, Product Quality Engineering, 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 (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 device acceptance and incoming inspection to meet targets

Lead root cause investigations regarding non-conforming product

Lead and support continuous process improvements related to device acceptance and incoming inspection

Lead Material Review Board and dispositioning of 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 and 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 OrganOx''s Code of Conduct and all other company policies

Skills and Experience / Requirements

2-5 years of 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

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

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, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.

LocationOxfordshire, England, United Kingdom (onsite)

Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance

Industries

Non-profit Organizations and Primary and Secondary ..... full job details .....