Sr. QA Manager

Jobs via Dice; 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 to oversee quality assurance efforts at their Chelmsford facility. This role involves 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 regulations.

Benefits

Comprehensive benefits package

16% annual bonuses

RSUs

Qualifications

• Minimum of 5+ years management experience in the medical device industry.
• 10+ years overall experience required.
• Extensive knowledge of 21 CFR Part 820 and ISO 13485.

Responsibilities

• Lead QA for balloon pump and balloon catheter products.
• Develop and implement QA strategies for compliance.
• Ensure QMS complies with FDA and ISO standards.

Skills

FDA audits

Medical device compliance

Quality Management System (QMS)

Education

Bachelor's Degree

Job description

Job Title: Senior Quality Assurance Manager

Join to apply for the Senior Quality Assurance (QA) Manager role at Piper Companies.

Location: Chelmsford, MA (Onsite, M-F schedule)

Overview: Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility. The role involves ensuring compliance with regulatory standards and driving continuous improvement initiatives.

Responsibilities:

• Lead QA for two products: balloon pump and balloon catheter.
• Develop and implement QA strategies to ensure compliance and quality 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 standards.

Qualifications:

• Minimum of 5+ years management experience in the medical device industry and 10+ years overall experience.
• Strong experience with FDA audits, including leading audits.
• Extensive knowledge of medical device compliance, especially 21 CFR Part 820 and ISO 13485.
• Bachelor's Degree required.
• Experience with catheters is a plus.
• Must work onsite in Chelmsford, MA, 5 days a week.
• Must be eligible to work in the United States.

Compensation:

• $160,000 - $175,000 plus 16% annual bonuses and RSUs.
• Comprehensive benefits package.

Application opens on May 23rd, 2025. Applications will be accepted for at least 30 days.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Medical Devices