Product Acceptance Engineer - Remote

About the position

Stryker is hiring a Product Acceptance Engineer to act as the primary liaison between Quality Assurance and Operations within the Finished Goods Operations team. In this role, you will provide expert QA and scientific support to help achieve operational goals. You will also be responsible for ensuring sterility compliance of medical devices in accordance with regulatory standards, leading the testing, monitoring, and validation of cleaning and sterilization processes and related utilities.

Responsibilities

• Lead and improve lot review and release processes within Finished Goods Operations.
• Drive continuous improvement initiatives across inspection and acceptance activities, expanding beyond Finished Goods.
• 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.

Requirements

• Bachelor's degree in Science, Engineering, or a related field.
• 0+ years of experience.

Nice-to-haves

• Experience in working in a compliance risk situation.
• Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Previous experience with ERP systems (SAP, Oracle etc.)

Benefits

• $69,100.00 - $139,600.00 salary plus bonus eligible + benefits.