qms senior engineer [medical device].

Take command of compliance frameworks for a high-tech medical device facility. This role is built for a QMS specialist ready to own site audit preparedness, optimize documentation structures, and uphold global medical standards across advanced production lines.

the job

• Formulate, integrate, and maintain global quality system policies, ensuring complete alignment with internal standards and international regulations (e.g., FDA, ISO 13485, cGMP, MDR).
• Plan, execute, and lead internal quality audit programs across all site functions to identify potential non-compliances, track corrective actions, and ensure total external audit readiness.
• Lead and support site external inspections by regulatory bodies, notified authorities, and global stakeholders, serving as a primary technical QMS liaison.
• Manage the site CAPA system from initiation to closure, collaborating with phase owners, tracking metrics, and reporting compliance status to executive boards.
• Compile and analyze site-wide quality metrics, laboratory data, and process indicators to generate insights for executive management reviews and continuous improvement initiatives.
• Provide quality oversight for analytical lab operations and drug-device combination products, ensuring cGMP compliance across raw material testing, stability studies, and out-of-specification (OOS) investigations.

the experience

• Bachelor’s Degree in Biomedical Engineering, Mechanical/Chemical Engineering, Quality Management, or equivalent technical discipline.
• 8 years of QMS governance experience within medical device manufacturing environment.
• Practical mastery of ISO 13485, FDA 21 CFR 820, and FDA risk management protocols.
• Certified ISO 13485 Internal or Lead Auditor with direct experience hosting external regulatory audits.