Product Quality Engineer

Product Quality Engineer – Organ Ox

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This range is provided by Organ Ox. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$:rd, please do not use variable binding for instruction: $/yr - $/yr

Organ Ox has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the Organ Ox Metra® . This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast‑paced global medical device company committed to improving transplantation outcomes.

As part of our ongoing expansion in North America, we seek a motivated Product работу Quality Engineer to join our team.

The Product Quality Team at Organ Ox is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization. The Product Quality Engineer will be technical, hands‑on, and customer focused with an ability to analyze, diagnose, and test product quality issues. The successful candidate is accountable, collaborative, has excellent communication and problem‑solving skills, and is passionate about delivering world‑class products that make healthcare more accessible, simpler, and safer.

Major responsibilities of the role are listed below with brief descriptions of key tasks. This list is not exhaustive.

• Conduct hands‑on analyses of returned products to identify root causes of failures.
• Develop investigation criteria and test methods to diagnose and root‑cause field failures.
• Analyze and trend product performance data to provide recommendations for product improvements.
• Perform quality trending of service data and investigate causes of servicing/compliance complaint trends, including workmanship and out‑of‑box failures.
• Review submit outputs of servicing and related complaint investigations to ensure compliance with regulatory and service requirements.
• Audit and review complaint investigations and servicing records for completeness, accuracy, and timeliness.
• Democrativly analyze service‑relatedжем PFMEAs and other post‑market risk‑management activities.
• Provide ongoing training to service staff on regulatory requirements for complaint investigations and servicing records.
• Foster supplier relationships and support supplier corrective action requests.
• Support product transfer teams by aligning on quality requirements and processes for new or transferred products.
• Plan, develop, and validate service manuals, service work instructions, test method validations, and inspection method validations.
• Participate in the development and review of engineering change orders impacting servicing activities.
• Work with engineering to design and implement tooling, fixturing, and error‑proofing for servicing activities.
• Collaborate cross‑functionally to support changes in servicing and inspection procedures to mitigate field failures.
• Support CAPAs, escalations, DCNs, and other engineering projects addressing field quality issues.
• _VALisk service history records and PFMEA reviews to support complaint investigations.
• Adhere to the letter and spirit of Organ Ox ’ s Code of Conduct and all other company policies.

• Excellent technical report‑writing skills.
• Strong root‑cause analysis, design of experiments, and test‑method development experience related to servicing activities and complaint or non‑conformance investigations.
• Experience leading investigations and trending analysis, troubleshooting electro‑mechanical systems, and engineering custom test fixtures for functional and performance validation.
• Ability to manage multiple investigations and projects independently.
• Solid understanding of FDA QSR Quality System Requirements and ability to apply the knowledge.
• Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.).
• Strong experience with statistical…