Piper Companies
Join to apply for the
Sr. QA Manager
role at
Piper Companies 1 day ago Be among the first 25 applicants Join to apply for the
Sr. QA Manager
role at
Piper Companies 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 30th, 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 Referrals increase your chances of interviewing at Piper Companies by 2x Sign in to set job alerts for “Senior Quality Assurance Manager” roles.
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Sr. QA Manager
role at
Piper Companies 1 day ago Be among the first 25 applicants Join to apply for the
Sr. QA Manager
role at
Piper Companies 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 30th, 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 Referrals increase your chances of interviewing at Piper Companies 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
Marlborough, MA $130,000.00-$155,000.00 2 weeks ago Director, Quality Assurance - Medical Device
Chelmsford, MA $160,000.00-$175,000.00 1 day ago 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.
#J-18808-Ljbffr