Quality Engineer - Oxenham Group LLC

Our client, a leading medical device manufacturer, is seeking a Quality Engineer (Contractor) with a strong background in Corrective and Preventive Actions (CAPA). This role will focus on identifying, investigating, and closing CAPA projects to ensure compliance with regulatory standards. The ideal candidate will bring hands-on experience in quality engineering within the medical device industry, particularly around product lifecycle management, regulatory submissions, and continuous improvement initiatives.
Key Responsibilities:

• CAPA Management: Lead the investigation, root cause analysis, and resolution of CAPAs to ensure timely closure in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
• Risk Management: Perform risk assessments and implement mitigation strategies to ensure product safety and compliance.
• Data Analysis: Analyze nonconformances, complaints, and audit findings to initiate appropriate CAPA activities.
• Collaboration: Work cross-functionally with R&D, manufacturing, and regulatory teams to ensure CAPAs are addressed thoroughly and effectively.
• Documentation: Ensure that all CAPA-related documentation is accurate, complete, and maintained in accordance with the company's quality management system (QMS).
• Process Improvement: Identify areas of improvement in the CAPA process and recommend enhancements to streamline investigations and closures.
• Audits Support: Participate in internal and external audits, providing CAPA documentation and ensuring audit readiness.

Qualifications:

• Experience: Minimum of 3-5 years in quality engineering, with a specific focus on medical devices.
• CAPA Expertise: Strong background in CAPA investigations, root cause analysis (e.g., 5 Whys, Fishbone), and corrective action implementation.
• Regulatory Knowledge: In-depth understanding of FDA regulations, ISO 13485, and QMS processes.
• Education: Bachelor's degree in engineering, life sciences, or a related field. Advanced certifications (e.g., CQE, Six Sigma Green Belt) are a plus.
• Skills: Strong analytical, problem-solving, and communication skills. Experience with quality tools such as FMEA, SPC, and 8D.