Senior Quality Assurance Manager

Piper Companies is seeking a Senior Quality Assurance Manager to join a trusted leader advancing the future of medicine for a full-time, onsite permanent position located in Chelmsford, MA. The Senior Quality Assurance Manager will lead quality assurance efforts for balloon pumps and balloon catheters, ensuring regulatory compliance, driving excellence, and fostering a strong quality culture within the organization.

Responsibilities of the Senior Quality Assurance Manager include:

• Oversee quality assurance for balloon pumps and balloon catheters, ensuring top-tier performance and reliability.
• Design and implement QA strategies that uphold compliance and drive excellence.
• Cultivate a strong organizational commitment to quality.
• Maintain alignment of the Quality Management System (QMS) with global standards, including FDA 21 CFR Part 820 and ISO 13485.

Qualifications for the Senior Quality Assurance Manager include:

• 5+ years of management experience in the medical device industry and 10+ years of overall experience.
• Proven track record in FDA audits, including leadership experience in audit processes.
• Deep expertise in medical device compliance, specifically 21 CFR Part 820 and ISO 13485.
• Onsite work required, five days a week in Chelmsford, MA; must be eligible to work in the United States.
• Bachelor's degree required; catheter experience is a plus.

 Compensation for the Senior Quality Assurance Manager:

• Salary Range: $160,000 - 175,000 + 16% annual bonus/RSUs.
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 5/27. Applications for this job will be accepted for at least 30 days from the posting date.