Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule. The Senior Quality Assurance Manager is pivotal in ensuring compliance with regulatory standards and driving continuous improvement initiatives.

QUALIFICATIONS FOR THE SENIOR QUALITY ASSURANCE MANAGER INCLUDE:

• Minimum of 5+ years of management experience in the medical device industry and 10+ years overall experience.
• Strong experience with FDA audits, including some experience in leading audits.
• Extensive experience with compliance of medical devices, specifically 21 CFR Part 820 and ISO 13485.
• Experience with catheters is a bonus.
• Must work onsite 5 days a week in Chelmsford, MA.
• Must be eligible to work in the United States.

• Lead quality assurance for two products: balloon pump and balloon catheter.
• Develop and execute QA strategies to ensure compliance and excellence.
• Foster a culture of quality across the organization.
• Ensure the Quality Management System (QMS) complies with global standards, including FDA 21 CFR Part 820 and ISO 13485.