Sr Compliance Engineer

Coordinate and participate in Third‑party audits such as ISO 13485, FDA, and internal/external audits; track action plans; implement continuous improvement initiatives based on regulatory compliance requirements.

• Identify and implement continuous improvement initiatives based on current and forthcoming regulatory compliance requirements.
• Provide training, guidance, and coaching to Reynosa team members and site management on audit processes, documentation of findings, and development and evaluation of audit action plans.
• Monitor timely completion of corrective action plans and report compliance metrics to site manufacturing facilities management during management reviews.
• Serve as a subject‑matter expert for regulatory compliance and auditing issues.
• Train employees on national and international standards and regulations,...