Sr. QA 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 to oversee quality assurance efforts in a medical device facility. The role involves ensuring compliance with regulatory standards and fostering a culture of quality. Applicants must have extensive experience in the medical device industry and be prepared to work onsite in Chelmsford, MA.

Benefits

Comprehensive benefits package

Qualifications

• 5+ years management experience in medical device industry.
• Strong experience with FDA audits.

Responsibilities

• Lead quality assurance for two products: balloon pump and catheter.
• Develop and execute QA strategies for compliance.

Skills

Management

Compliance

Quality Assurance

Education

Bachelor's Degree

Job description

Join to apply for the Sr. QA Manager role at Jobs via Dice.

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Zachary Piper Solutions, LLC, is seeking the following. Apply via Dice today!

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