Staff Engineer, Post Market Quality

Work Flexibility: Hybrid

Stryker is hiring a Staff Engineer, Post Market Quality to support our Instruments division in Portage, MI to provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulations and standards.​ 

What you will do:

• ​​ Partner with operations, business functions, and cross-functional teams to ensure high-quality product performance and continuous process improvement.

• Engage with customers, sales, marketing, and field personnel to address top quality issues and drive resolution.

• Mentor and provide oversight in NC/CAPA processes, leading root cause investigations and corrective actions.

• Lead improvements in manufacturing processes, oversee concessions, and ensure robust change management practices.

• Act as a subject matter expert in risk management, human factors, and regulatory compliance, supporting audits and validation strategies.

• Analyze KPI trends, drive process enhancements, and optimize inspection methods and sampling strategies.

• Support plant transfers, lead quality activities, and manage product holds for potential escapes.

• Provide technical guidance, mentor teams, and promote quality best practices across the organization.

What you need:

Required:

• Bachelor's degree in a science or engineering related discipline

• Minimum of 4+ years’ of experience in a regulated environment, adhering to GDP and GMP standards.

• Expertise in Quality Concepts, including Risk Management, CAPA, Audits, and Statistical Analysis, to drive process improvements and compliance.

Preferred:

• Utilized advanced statistical methods to analyze data, drive decision-making, and improve quality processes.

• Leveraged Power BI to analyze and visualize data from Excel, providing actionable insights for decision-making.

• Applied knowledge of SiMD/SaMD to support software-driven medical device processes and regulatory compliance.

• Experienced in engaging with regulatory agencies (FDA, MoH, TUV) and ensuring compliance with U.S. and international medical device regulations.

• Managed post-market quality processes, including compliance monitoring, risk assessment, and continuous improvement initiatives.​

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.