Quality Assurance Post Market Specialist

Work Flexibility: Hybrid

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

• Bachelors 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: $83400 - $139000 USD Annual

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

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 contractors legal duty to furnish information.