Quality Sr. Manager - Medical Devices

• Lead the site Quality organization and serve as the primary representative for quality and regulatory matters.
• Ensure compliance with FDA, cGMP, ISO, and other applicable global regulations.
• Oversee and continuously improve the Quality Management System (QMS).
• Drive quality strategy, operational excellence, and harmonization of quality processes across the organization.
• Lead investigations, CAPA activities, quality metrics reviews, and risk mitigation initiatives.
• Assess Quality team capabilities, identify organizational gaps, and implement development plans.
• Champion the transition from manual processes to digital and AI-enabled quality solutions.
• Promote a mindset of accountability, collaboration, and continuous improvement.
• Partner with Manufacturing, Engineering, Supply Chain, and other stakeholders to improve business performance.
• Drive budget adherence, cost-control initiatives, and sustainable quality improvements.

QMS for Class II/III medical device manufacturingDesign Transfer, Validation, Supplier Quality, and FDA/ISO compliance.

• Bachelor's degree in Engineering, Science, or related technical field; advanced degree preferred.
• 10+ years of Quality experience within Medical Devices and/or Pharmaceutical manufacturing.
• 5+ years leading managers and multidisciplinary Quality teams.
• Strong expertise in Class II/III medical device manufacturing processes, Design Transfer, Manufacturing Specifications, Supplier Qualification, Validation Strategy, and Production & Process Controls.
• Extensive knowledge of FDA 21 CFR, cGMP, ISO 13485, and regulated manufacturing environments.
• Demonstrated success leading organizational change and improving team performance.
• Strong analytical, problem-solving, and root cause investigation skills.
• Excellent communication, stakeholder management, and executive influencing capabilities.
• Experience identifying quality gaps, solving market-impacting quality issues, and driving measurable operational improvements.

Competitive Compensation Package