Quality Manager Operations

About the role

The Quality Manager Operations will lead the Quality Engineering function and broader Quality Assurance activities at the site level. You will ensure compliance with global regulatory standards, drive strategic quality initiatives, and build high‑performing teams in a regulated health‑technology environment.

Key responsibilities

• Lead and oversee Quality Engineering and QA operations, ensuring full compliance with FDA, ISO 13485 and corporate quality requirements.
• Drive strategic quality initiatives such as CAPA programs, non‑conformance resolution, process validation and continuous improvement.
• Maintain site audit readiness by managing internal and external audits, coordinating regulatory interactions and sustaining robust quality systems.
• Partner with site leadership and global teams to align quality strategies, monitor performance metrics, oversee supplier quality and product transfers, and represent the site in global quality governance forums.
• Develop talent through coaching, succession planning and team leadership.

Required profile

• 7+ years of experience in Quality or Manufacturing within a regulated industry.
• Proven leadership in cross‑functional environments with responsibility for audits, CAPA and validation programs.
• Bachelor's or master's degree in Engineering, Science or a related field.
• Strong communication, problem‑solving abilities and capacity to operate in complex global structures.

Required skills

• FDA regulatory knowledge
• ISO 13485 compliance
• CAPA management
• Process validation
• Audit management
• Quality systems expertise
• Supplier quality management
• Performance metrics analysis

What we offer

• Opportunity to work in a leading health‑technology company.
• Collaborative environment with hybrid work (minimum 3 days onsite per week).
• Professional development and leadership growth.