Quality Assurance, Post Market Specialist
Stryker
Summary
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.
Job description
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.
Requirements
- 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
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.