Quality Assurance, Post Market Specialist

Stryker; Redmond (WA); On-site; USD 83,000 - 139,000; Full time

Job summary

Stryker is seeking a Quality Assurance Post Market Specialist to help ensure the safety, quality, and effectiveness of its products. You will partner with cross-functional teams to evaluate complaints, support regulatory reporting, contribute to field actions, and maintain compliance with global post-market surveillance regulations, ultimately supporting patient safety and product performance.

The role involves collaborating with Quality, Engineering, Clinical, and Marketing teams to aid

Qualifications

• 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 Word and Microsoft Excel.

Responsibilities

• 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.

Skills

Communication

Analytical thinking

Documentation

Cross-functional collaboration

MS Office

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Job description

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.