Engineer, Quality Assurance

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Quality Assurance Engineer (Hybrid), in Portage, MI to support Medical Acute Care! In this role, you will be supporting Post Market and responsible for continuous product and process quality improvements. You will conduct investigations into complaints/services, NCs, and CAPAs stemming from the products in the field, lead root cause activities and identify potential failure modes and risks to resolve customer issues.

Work Flexibility: Hybrid. This role requires proximity to our Stryker facility in Portage, MI, with at least three core onsite days (Monday-Wednesday). Additional onsite days may occasionally be required based on project needs.

What you will do:

• Investigate and address sensitive customer complaints promptly, ensuring compliance with global regulations and thorough communication with customers, field service, and sales teams to gather necessary information, documenting results in the Complaint Handling System.
• Collect, analyze, and present post-market data (such as service reports, complaints, and costs associated with poor quality) to identify and drive quality improvement opportunities within the Medical Division.
• Lead and support Nonconformances (NC) and Corrective and Preventive Actions (CAPA) processes, including those that lead to field action assessments, by collaborating with cross-functional teams (R&D, Operations, Manufacturing, etc.) to identify root causes and implement corrections and corrective action. 
• Facilitate product changes through sustainment, including Engineering Change Orders (ECO) and Process Change Orders (PCO), and develop rationales for verification or validation testing to resolve post-market issues.
• Maintain and update risk management documentation throughout the product lifecycle, conducting risk assessments as needed to ensure current risk evaluation is complete and accurate.
• Provide post-market feedback on safety, durability, craftsmanship, and reliability to inform design input specifications for quality reports, design reviews, and customer research.
• Support ongoing quality assurance for products post-launch by monitoring market feedback and customer input to improve safety and effectiveness.
• Monitor compliance with Medical Quality Procedures, FDA, and other global health regulations, and assist with internal and external audits (FDA, ISO, MDSAP, etc.).

What you need:

Required:

• Bachelor’s degree in an Engineering related disciple is required with no prior work experience necessary.

Preferred:

• Preferred 1-2 years of engineering experience in a regulated industry (medical device, pharmaceutical, or FDA-regulated).
• Basic knowledge of industry regulations (FDA QSR, ISO 13485, ISO 14971).
• Proficiency in Microsoft Office (Outlook, Excel, Word).

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.