Senior Quality Assurance Manager

Jobs via Dice; Chelmsford (MA); On-site; USD 160,000 - 175,000; Full time

Job summary

A leading company is seeking a Senior Quality Assurance Manager for its Chelmsford facility. In this pivotal role, you will lead quality assurance efforts for medical devices, ensuring compliance with regulatory standards and driving quality improvement initiatives. The successful candidate will require significant experience in the medical device industry and a Bachelor's degree.

Benefits

Comprehensive benefits package

Qualifications

• 5+ years management experience in medical devices.
• Experience leading FDA audits.
• Strong compliance knowledge with FDA and ISO standards.

Responsibilities

• Lead quality assurance for medical device products.
• Develop and execute QA strategies for compliance.
• Ensure adherence to Quality Management System standards.

Skills

FDA audits

Compliance with 21 CFR Part 820

ISO 13485 compliance

Education

Bachelor's Degree

Job description

Join to apply for the Senior Quality Assurance Manager role at Jobs via Dice

1 day ago Be among the first 25 applicants

Join to apply for the Senior Quality Assurance Manager role at Jobs via Dice

Get AI-powered advice on this job and more exclusive features.

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 bonRSUs.
• Comprehensive benefits package.
  
  

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Software Development

Referrals increase your chances of interviewing at Jobs via Dice by 2x

Sign in to set job alerts for “Senior Quality Assurance Manager” roles.

Methuen, MA $120,000.00-$140,000.00 2 weeks ago

Director of Clinical Quality Assurance – Pharmacovigilance

Lowell, MA $105,000.00-$125,000.00 2 days ago

Nashua, NH $146,670.00-$249,330.00 1 week ago

Sr. Quality Assurance Manager - Manufacturing/Med Device

Chelmsford, MA $160,000.00-$175,000.00 1 day ago

Marlborough, MA $130,000.00-$155,000.00 2 weeks ago

Chelmsford, MA $160,000.00-$175,000.00 1 day ago

Director, Quality Assurance - Medical Device

Chelmsford, MA $160,000.00-$175,000.00 1 day ago

Division Director of Quality Assurance-Human Services

Fitchburg, MA $87,131.00-$87,131.00 1 month ago

Senior Manager Manufacturing (CMC) Quality Assurance

Senior Director, GCP/GLP Quality Assurance

Director, Clinical Quality Assurance, Pharmacovigilance

Sr Manager, QA Document Control & Training

Topsfield, MA $118,000.00-$160,000.00 1 week ago

Sr. Quality Assurance Manager - Manufacturing/Med Device

Senior Manager, Quality Assurance Contamination Control and Sterility Assurance (Hybrid)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.