Senior Quality Compliance Specialist, Post Market

Stryker is hiring a Senior Quality Compliance Specialist, Post Market for our Ortho Tech division in Portage, MI. This role supports product complaint investigations and regulatory compliance activities to help ensure product quality and patient safety. The individual will work closely with cross-functional and global teams to investigate product issues, contribute to risk assessments, support regulatory reporting (e.g., MDR/MIR), and assist with recall activities when needed. This is a hands-on role with opportunities to build foundational experience in quality, regulatory, and complaint handling processes.

What you will do:

• Support product complaint investigations, including gathering information, assisting with root cause analysis, and documenting findings.
• Help ensure compliance with regulatory requirements by supporting audits, documentation reviews, and adverse event reporting (MDR/MIR).
• Assist in executing corrective and preventive actions (CAPA) and tracking follow-up activities to closure.
• Monitor product performance trends and escalate potential issues or risks to senior team members.
• Contribute to recall activities, including supporting communications, product tracking, and documentation.
• Collaborate with cross-functional and global teams (RA/QA, engineering, manufacturing) to obtain information and resolve issues.
• Review complaint records and documentation for completeness, accuracy, and proper classification.
• Communicate with internal teams and customers to collect required information and provide updates on complaint status.

What you need:

Required

• Bachelor degree in Engineering, Science, Regulatory Science or related degree
• Minimum of 2 years’ experience in an engineering, quality, regulatory or related role.

Preferred

• Previous experience in the medical device industry with exposure to regulatory interactions (e.g., FDA, MoH, TÜV), and working knowledge of U.S. and international regulations and quality standards such as ISO 13485, GMP, and GDP.
• Working knowledge of quality principles (e.g., risk management, CAPA, audits, basic statistics) with experience supporting activities in regulated or compliance-driven environments.
• Applies structured problem-solving approaches (e.g., 5 Whys, Fishbone) and time management tools to effectively prioritize work, support investigations, and manage multiple tasks in a fast-paced, regulated environment.

USN : $69,500 - $110,900 USD Annual