Overview
On Site
Full Time
Skills
Pivotal
Continuous Improvement
Quality Management
QMS
Management
Auditing
Regulatory Compliance
Medical Devices
ISO 13485
Mergers and Acquisitions
Quality Assurance
Job Details
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:
Qualifications for the Senior Quality Assurance Manager include:
Compensation for the Senior Quality Assurance Manager includes:
This job opens for applications on April 30th, 2025 . Applications for this job will be accepted for at least 30 days from the posting date.
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.
- 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 April 30th, 2025 . Applications for this job will be accepted for at least 30 days from the posting date.
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