Product Acceptance Engineer - Remote
Work Flexibility: Remote
Product Acceptance Engineer - Remote
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.
What you will do:
- 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.
What you need:
Basic Qualifications:
- Bachelor’s degree in Science, Engineering, or a related field
- 0+ years of experience
Preferred Qualifications:
- 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,)
$69,100.00 - $139,600.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 10%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. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.Originally posted on Himalayas
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