Quality Manager

About the role

Biomerics is seeking a Quality Manager to lead and maintain its quality management system across all operations. The role ensures full compliance with customer requirements, regulatory standards, and internal policies while supporting the company’s mission to deliver innovative medical device solutions.

Key responsibilities

• Implement and maintain quality systems in line with ISO 9001, ISO 13485 and CFR 21 Part 820.
• Audit the effectiveness of the quality system and drive continuous improvement.
• Lead advanced product quality planning, risk management, and CAPA processes.
• Coordinate measurement system evaluations, equipment calibration, and verification activities.
• Conduct subcontractor quality inspections and audits.
• Manage customer quality issues, non‑conforming product disposition, and document control.
• Oversee Part Approval Process (PPAP) submissions and support business planning activities.
• Investigate product complaints and ensure corrective actions are implemented.

Required profile

• Strong understanding of medical device quality standards and regulatory requirements.
• Experience with quality system audits and continuous improvement initiatives.
• Ability to work cross‑functionally with engineering, manufacturing, and external partners.
• Excellent analytical and problem‑solving skills.

Required skills

• ISO 9001
• ISO 13485
• CFR 21 Part 820
• Risk management
• CAPA (Corrective and Preventive Actions)
• Measurement equipment calibration
• PPAP (Part Approval Process)
• Audit techniques
• Document control
• Microsoft Office proficiency