Quality Assurance Manager

Qualifications

• 10+ years of experience in Quality within the medical device industry preferred
• Bachelor’s degree in Engineering or related field, preferred or equivalent work experience
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and MDSAP, preferred
• Proven experience leading regulatory inspections and audits (FDA, ISO, MDSAP), preferred
• Experience with sterile products and external sterilization processes preferred
• Strong analytical skills with demonstrated ability to drive data-based, risk-informed decisions
• Proven leadership in team development, cultural transformation, and employee engagement
• Excellent communication skills with ability to influence across all organizational levels and external stakeholders

Responsibilities

• Own and lead the development, implementation, and continuous improvement of the site Quality Management System, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements.
• Provide strategic leadership and direction to the Quality function, aligning quality objectives with business goals while maintaining the highest standards of compliance, product quality, and patient safety.
• Oversee quality assurance activities for sterile and non-sterile products, including control, release, and oversight of sterile product received from external sterilization providers, ensuring integrity, traceability, and compliance throughout distribution.
• Lead and make risk-based decisions impacting product quality, including the establishment and management of QA holds driven by customer complaints, internal quality signals, or business needs.
• Lead and represent the site during regulatory inspections and audits, including FDA, MDSAP, ISO, and customer audits, ensuring effective preparation, execution, and timely closure of observations.
• Drive robust complaint handling and investigation processes, ensuring timely containment, thorough root cause analysis, and effective corrective and preventive actions (CAPA).
• Actively monitor, analyze, and drive improvements based on quality data and KPIs, identifying trends, mitigating risks, and supporting product release decisions.
• Lead Site Quality Management Reviews, effectively communicating performance metrics, risks, and improvement plans to senior leadership.
• Lead, coach, and develop a high-performing Quality organization, fostering a positive, accountable, and engaging work environment, recognizing that strong culture and employee engagement are critical to compliance and operational success.
• Promote a strong culture of quality, compliance discipline, and contamination control awareness across all levels of the organization through clear, consistent, and effective communication.