Regulatory Affairs Specialist – Medical Devices
Vision RT Ltd
Staff Quality Engineer
Evergen (Formerly RTI Surgical)
contract
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $130,000 - $145,000 per year
Job Level
Lead
About the role
- Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.
- Own and optimize quality system processes (e.g., CAPA, supplier quality, complaint handling, statistical techniques).
- Lead complex investigations and implement systemic corrective/preventive actions.
- Provide expertise in reliability engineering, process validation, and design for quality.
- Represent the company as a quality expert during FDA inspections, notified body audits, and supplier audits.
- Collaborate with executive leadership to align quality strategies with business objectives.
- Mentor and coach quality engineers across multiple sites or functions.
Requirements
- Bachelor’s or Master’s degree in engineering, life sciences, or related discipline.
- 8+ years of progressively responsible quality experience in the medical device industry.
- Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP).
- Proven success leading cross-functional projects and influencing at senior levels.
- Advanced statistical analysis, risk management (ISO 14971); Six Sigma Black Belt preferred.
- Track record of leading successful audits and remediation projects.
- Certifications preferred: AATB or CTBS, Lead Auditor, ASQ – CQE, CBA, or CQA.
- Skills: Excellent verbal and written communication; Technical writing; Problem solving methodologies; Microsoft Office Suite; Quality Management System software; Investigations; Statistical techniques.
- Travel: Up to 25% including international.
- Physical requirements: Move or lift objects up to 25 pounds; frequent stationary position (>75% standing or sitting while utilizing digital displays); frequent fine manipulation (>75% typing, opening, writing, clicking, paper sorting, etc.).
