Stryker Corporation is hiring a Product Acceptance Engineer to join the Finished Goods Operations team. In this remote position, you will act as the primary liaison between Quality Assurance and Operations, providing expert QA and scientific support to achieve operational goals and ensure the sterility compliance of medical devices.
What You'll Do
- Lead and improve lot review and release processes within Finished Goods Operations.
- Drive continuous improvement initiatives across inspection and acceptance activities.
- Provide quality expertise and support across functions, including NC/CAPA ownership and resolution.
- Ensure compliance with sterility standards through oversight of environmental monitoring, utilities, and sterilization processes (EtO, radiation).
- Review and validate cleaning and sterilization protocols in line with ISO standards.
- Analyze sampling and monitoring data using statistical techniques to identify trends and trigger actions.
- Act as microbiology technical lead in cross-functional teams, supporting product and process issues.
- Support external audits (FDA, IMB, BSI) and contribute to procedure development and training.
What We're Looking For
- Bachelor’s degree in Science, Engineering, or a related field.
- 0+ years of experience.
Nice to Have
- Experience working in a compliance risk situation.
- Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise.
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Previous experience with ERP systems (SAP, Oracle etc.).
Technical Stack
- ERP systems (SAP, Oracle)
Team & Environment
You will join the Finished Goods Operations team.
Benefits & Compensation
- Bonus eligible
- Benefits
- Compensation Range: $69,100.00 - $139,600.00
Work Mode
This position is remote.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
