Senior Quality Assurance Manager

Piper Companies; Boston (MA); On-site; USD 160,000 - 175,000; Full time

Benefits offered by this job

Annual bonus/RSUs

Comprehensive benefits

Job summary

Piper Companies is seeking a Senior Quality Assurance Manager to lead QA efforts for a medical device facility in Chelmsford, MA on a Monday–Friday onsite schedule.

The role requires strong experience in regulatory compliance (FDA 21 CFR Part 820, ISO 13485) and a track record of building quality cultures across teams. You will oversee QA for balloon pump and balloon catheter products and ensure the QMS remains compliant.

Qualifications

• Minimum 5+ years of management experience in medical devices.
• 10+ years of overall experience.
• Experience with FDA audits, including leading audits.
• Bachelor's Degree required.

Responsibilities

• 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 FDA 21 CFR Part 820 and ISO 13485.

Skills

Quality Assurance

Regulatory compliance

Leadership

FDA audits

GMP

Education

Bachelor's Degree

Job description

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.

Responsibilities

• 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

• 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 and Benefits

Compensation for the Senior Quality Assurance Manager includes: $160,000 - 175,000 + 16% annual bonus/RSUs.

Comprehensive benefits package.