Senior Quality Assurance Manager
$160k - $175kPiper 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. Responsibilities 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 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 and Benefits Compensation for the Senior Quality Assurance Manager includes: $160,000 - 175,000 + 16% annual bonus/RSUs. Comprehensive benefits package. #J-18808-Ljbffr Piper Companies
Vacancy posted 1 day ago
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