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Senior Quality Assurance Manager

Piper Companies

Chelmsford (MA)

On-site

USD 160,000 - 175,000

Full time

9 days ago

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Job summary

Piper Companies is seeking a Senior Quality Assurance Manager for a full-time, onsite position in Chelmsford, MA. The successful candidate will lead QA efforts for medical devices, ensuring compliance with regulations while cultivating a strong quality culture within the organization.

Benefits

Medical Benefits
Dental Benefits
Vision Benefits
401K

Qualifications

  • 5+ years of management experience in the medical device industry.
  • Proven track record in FDA audits and compliance.
  • Deep expertise in 21 CFR Part 820 and ISO 13485.

Responsibilities

  • Oversee quality assurance for balloon pumps and catheters.
  • Design and implement QA strategies for compliance.
  • Align QMS with FDA and global standards.

Skills

Regulatory Compliance
Quality Assurance
Leadership

Education

Bachelor's Degree

Job description

Join to apply for the Senior Quality Assurance Manager role at Piper Companies

1 day ago Be among the first 25 applicants

Join to apply for the Senior Quality Assurance Manager role at Piper Companies

Piper Companies is seeking a Senior Quality Assurance Manager to join a trusted leader advancing the future of medicine for a full-time, onsite permanent position located in Chelmsford, MA. The Senior Quality Assurance Manager will lead quality assurance efforts for balloon pumps and balloon catheters, ensuring regulatory compliance, driving excellence, and fostering a strong quality culture within the organization.

Responsibilities of the Senior Quality Assurance Manager include:

  • Oversee quality assurance for balloon pumps and balloon catheters, ensuring top-tier performance and reliability.
  • Design and implement QA strategies that uphold compliance and drive excellence.
  • Cultivate a strong organizational commitment to quality.
  • Maintain alignment of the Quality Management System (QMS) with global standards, including FDA 21 CFR Part 820 and ISO 13485.

Qualifications for the Senior Quality Assurance Manager include:

  • 5+ years of management experience in the medical device industry and 10+ years of overall experience.
  • Proven track record in FDA audits, including leadership experience in audit processes.
  • Deep expertise in medical device compliance, specifically 21 CFR Part 820 and ISO 13485.
  • Onsite work required, five days a week in Chelmsford, MA; must be eligible to work in the United States.
  • Bachelor's degree required; catheter experience is a plus.

Compensation for the Senior Quality Assurance Manager:

  • Salary Range: $160,000 - 175,000 + 16% annual bonus/RSUs.
  • Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 5/27. 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
    Business Consulting and Services

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