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Job description
Senior Quality Engineer, Complaint Handling
Stryker is hiring a Senior Quality Engineer, Complaint Handling for our Joint Replacement division in Weston, Florida. This role ensures compliance with FDA regulations by managing the timely closure of complaint records. It involves tracking and analyzing key process indicators to identify areas requiring improvement, conducting preliminary data collection and analysis for complaint investigations, and maintaining accurate records in investigation templates and the complaint database. The position supports management by providing actionable insights and ensuring adherence to regulatory requirements.
Work Flexibility: Hybrid.
The candidate must reside within a commutable distance to Weston, FL and is expected to be onsite at the facility multiple times/week.
What you will do:
- Responsible for maintaining a consistent product inspection throughput via triaging high priority investigations, communicating consistently with other staff on the status of work in process (WIP), and maintaining a first-in, first-out (FIFO) system to ensure product is inspected within established timelines.
- Performs inspection and testing to ensure that the products are free of flaws and function as designed
- Work with all products, manufacturing and quality teams to determine root cause and to ensure proper corrective actions have been identified, implemented and verified to be effective.
- Participate in continuous improvement and process re-engineering projects in support of Stryker Orthopedics’ continuous improvement initiatives.
- Generate and analyze metrics and make recommendations as required to Quality Engineers.
- Generate data for Competent Authorities (FDA, BSI and other regulatory bodies).
- Collaborate with consulting clinicians on medical dictations.
- Mentor, oversee and approve the work of other Product Complaint Analysts and Product Complaint Representatives by providing technical training and coaching to colleagues.
What you need:
Required:
- Bachelor's Degree in Science, Engineering or related discipline
- 2+ years’ experience working regulated environment
Preferred:
- Experience in Post-Market Surveillance
- Previous experience in Medical Device Industry
- Experience and knowledge with regulatory requirements, such as ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive.
- Ideal candidate would possess one or more of the below certifications; CQE, CRE, Lean Six Sigma Green or Black belt.
- Experience and ability to manage complex or broad scope projects
- Experience in working within Microsoft Office software including Excel, Word and Power Point.