Engineer, Quality Assurance

Quality Assurance Engineer

Stryker is hiring an Engineer, Quality Assurance in Lakeland, FL to support Sustainability Solutions. In this full-time role, you'll provide quality engineering support across assurance, control, and preventive activitiesdriving continuous improvement in both products and processes.

You will play a key part in supporting the transfer of manufacturing operations from our Lakeland site, which is expected to remain operational through the end of 2026. This is a great opportunity for someone early in their engineering career to gain hands-on experience in quality within a global medical technology leader. This role can also qualify for a retention bonus.

What You Will Do:

• Investigate customer complaints in accordance with FDA and global regulatory requirements, ensuring timely and compliant resolution.

• Communicate with customers, field service, and sales teams to collect data necessary for complaint investigations.

• Gather, analyze, and present post market trending data (e.g. service reports, complaints, MDR/MIR, cost of poor quality) to identify opportunities for quality improvements.

• Lead initiatives to improve Medical Division Quality metrics through data-driven actions and cross-functional collaboration.

• Lead and/or support NC and CAPA process by working with multifunctional teams (Ex: R&D, Operations, Manufacturing Engineering, Field Service, and Sales) to drive root cause and resolution. Document accurate and thorough investigation results within the Complaint Handing System.

• Support Engineering Change Orders (ECOs) and Process Change Orders (PCOs), including development of verification/validation rationale for post-market issues.

• Maintain and update product risk management documentation throughout the product lifecycle, including risk analyses and mitigation strategies.

• Contribute to post-launch quality assurance by monitoring product performance and integrating voice-of-customer feedback into design and quality specifications.

• Monitor compliance to Medical Quality Procedures, FDA, and other global health authority regulations.

• Support field action-related activities i.e., investigations, Health Hazard Evaluations (HHEs), and presentations.

• Support internal and external audits (FDA, ISO, MDSAP, etc.).

What You Need:

Required:

• Bachelor's degree in engineering, science, or related field.

• 0+ years of experience.

Preferred:

• Industry or regulation knowledge is a plus! (FDA QSR, ISO 13485, etc.)

• Internship or hands-on experience in engineering, quality assurance or manufacturing within a regulated industry.

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.