Manufacturing Quality Engineer

This range is provided by JCW Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$95,000.00/yr - $/yr

Senior Manufacturing Quality Engineer – Class III Medical Devices

We’re looking for a detail-oriented and collaborative Senior Manufacturing Quality Engineer (Sr. QE) to support the design, development, and commercialization of transcatheter mitral heart valve technologies. In this role, you’ll lead quality efforts across manufacturing processes to ensure compliance with global regulatory and quality standards, including FDA QSR, ISO 13485, ISO 5840, and EU MDR.

If you have hands‑on experience with process validation, process optimization, and manufacturing of Class III medical devices, this is an exciting opportunity to make an impact in life‑saving technology.

• Lead and execute process validation (IQ/OQ/PQ) for new and existing manufacturing processes.
• Manage software validation for manufacturing and quality systems, including protocol development, testing, and documentation.
• Develop and implement quality assurance policies and standards aligned with ISO 13485:2016.
• Conduct internal audits, support CAPA and NCMR activities, and drive root cause analysis for process issues.
• Collaborate cross‑functionally to improve manufacturing processes and product quality.
• Review and approve manufacturing process changes, ensuring regulatory compliance.
• Oversee cleanroom qualification and environmental monitoring programs per ISO 14644 and GMP requirements.
• Foster a culture of collaboration, quality, and continuous improvement across teams.

• Bachelor’s degree in Manufacturing, Mechanical, or Industrial Engineering (or related field).
• 7+ years of experience in manufacturing quality engineering within the medical device industry.
• Experience with process/test method validation, risk management, design controls, and DHF documentation.
• Familiarity with lean manufacturing and Six Sigma principles.
• Strong understanding of FDA QSR, ISO 13485, and global regulatory requirements.
• Proven ability to lead teams, manage multiple projects, and communicate effectively across disciplines.
• Certified Internal Auditor (ISO 13485:2016) preferred.

Mid‑Senior level

Full‑time

Quality Assurance, Analyst, and Engineering

Medical Equipment Manufacturing