Senior Quality Assurance Manager

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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.

Responsibilities of the Senior Quality Assurance Manager include:

• 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.

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.
• Bachelor's Degree required.
• 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.

Compensation for the Senior Quality Assurance Manager includes:

• $160,000 - 175,000 + 16% annual bonus/RSUs.
• Comprehensive benefits package.

This job opens for applications on May 27rd, 2025 . Applications for this job will be accepted for at least 30 days from the posting date.

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