Quality Assurance, Post Market Specialist

As the Quality Assurance Post Market Specialist , you will support activities that help ensure the safety, quality, and effectiveness of Stryker products. You will partner with cross-functional teams to evaluate product complaints, support regulatory reporting requirements, contribute to product field actions, and help maintain compliance with global post-market surveillance regulations. Your work will play an important role in supporting patient safety and product performance.

What You Will Do

• Support post-market surveillance activities to ensure compliance with U.S. and international regulatory requirements.
• Review product complaints and adverse event reports to assess reportability and determine whether device use contributed to patient harm.
• Interface with customers to collect patient information and additional details related to adverse event complaints.
• Collect, analyze, and report post-market adverse event data to regulatory agencies and cross-functional stakeholders.
• Support Product Field Action (PFA) and Medical Risk Assessment (MRA) activities.
• Provide quality and regulatory input for nonconformance investigations, CAPA activities, complaint investigations, and audit responses.
• Contribute to the development and maintenance of product hazard analyses and reportability guidance documents.
• Collaborate with Quality, Engineering, Clinical, and Marketing teams to support regulatory decision-making.
• Assist in preparing technical documentation and regulatory submissions.
• Maintain awareness of evolving global post-market surveillance regulations and industry requirements.

What You need

• Bachelor's degree
• 0-2 years of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry.
• Strong verbal and written communication skills.
• Strong analytical, organizational, and problem-solving abilities.
• Ability to compose, review, and edit technical documentation.
• Experience collaborating with cross-functional teams.
• Proficiency with Microsoft Office applications, including Word and Excel.

Preferred

• 1 year of post-market surveillance, quality, regulatory affairs, clinical, or related experience within a regulated industry.
• Experience within the medical device industry.
• Prior exposure to medical device product development.
• Clinical or nursing experience.
• Critical care monitoring experience.
• ECG rhythm interpretation skills.
• Familiarity with complaint handling, adverse event reporting, CAPA, risk management, and field action activities.

United States of America Pay Ranges:

• US15 : $83,400 - $139,000 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.