Sr. QA Manager

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

Job summary

A leading company in the medical device industry is seeking a Senior Quality Assurance Manager in Chelmsford, MA. This role involves leading QA efforts, ensuring compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will have extensive experience in the medical device sector and a strong background in FDA audits. This position offers a competitive salary and comprehensive benefits package.

Benefits

Comprehensive benefits package

Qualifications

• Minimum of 5+ years of management experience in the medical device industry.
• Strong experience with FDA audits and compliance with 21 CFR Part 820 and ISO 13485.

Responsibilities

• Lead quality assurance for balloon pump and balloon catheter products.
• Develop and execute QA strategies to ensure compliance and excellence.
• Foster a culture of quality across the organization.

Skills

Leadership

Quality Assurance

Compliance

Continuous Improvement

Education

Bachelor's Degree

Job description

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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 16th, 2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Senior Quality Assurance Manager, QA, Quality Assurance, Manager Chelmsford, medical device industry, FDA audits, 21 CFR Part 820, ISO 13485, compliance, quality management system, QMS, balloon pump, balloon catheter, regulatory standards, continuous improvement, team leadership, product quality assurance, documentation review, product testing, batch release, field actions, product recalls, site QMS documentation, internal audits, third-party audits, regulatory inspections, quality techniques, multinational matrix environment, business acumen, audit experience, engineering degree, medical degree, science degree, leadership experience, regulatory function, quality function, organizational capability, people development, systems development, process development, dynamic environment.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Business Consulting and Services

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