Senior Quality Manager

About This Role

Lead site-level quality functions for a medical device manufacturer, ensuring compliance with industry standards, driving audit readiness, and fostering a culture of right-first-time execution.

Responsibilities

• Develop, implement, and maintain quality management systems in line with industry standards
• Lead quality assurance and control initiatives to ensure product and process excellence
• Collaborate with cross-functional teams to identify and resolve quality-related issues
• Monitor production processes to ensure compliance with established quality standards
• Conduct regular audits and implement corrective actions as necessary
• Provide training and guidance to staff on quality processes and best practices
• Analyze quality data and generate reports to support decision-making
• Drive continuous improvement initiatives to enhance product quality and operational efficiency

Requirements

• Bachelor's degree in Engineering or scientific discipline
• Proven site Quality Manager experience in regulated manufacturing
• Medical device experience with ISO 13485 expertise
• Cleanroom manufacturing leadership experience
• 5-10+ years people leadership across quality functions
• Strong stakeholder influence and change leadership skills
• Expertise across QA, QMS, QC, and Supplier Quality
• Strong working knowledge of audit management

Qualifications

• Bachelor's degree in Engineering or scientific discipline
• 5-10+ years people leadership across quality functions, proven site Quality Manager experience in regulated manufacturing, and extensive quality leadership in medical device or life sciences

Skills

* Required skills

Benefits