#twiceasnice Recruiting
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.)
#twiceasnice Recruiting, Billerica, Massachusetts, us, 01821
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.)
Location: Billerica, MA (on-site)
Salary: $135,000 - $150,000 + Benefits
Benefits: Medical, Dental, Vision, Disability, Life Insurance, 401K w/ Match, PTO, Sick Days
Job Type: Full-Time
Typical Hours: Flexible 8-hour day, Monday-Friday between 7am-6pm
Start Date: ASAP
Sponsorship: Not Available
Relocation Assistance: Not Available
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Description
Our client, a manufacturer serving the medical industry, is seeking a
Quality
Manager
to join their team in Billerica, MA. This role leads a small, collaborative team while remaining hands-on approximately 70% of the time, focused on daily quality activities and 30% on planning, metrics, and reviews. The company recently completed an FDA audit and maintains a well-established Quality Management System focused on continuous improvement. The ideal candidate brings strong experience in
both Quality Management and Quality Control within the medical device industry , with a deep understanding of ISO Quality Systems, FDA, GMP, and QSR requirements. Success in this role requires a leader who enjoys balancing floor-level engagement with strategic oversight in a metric-driven environment. This is a great opportunity to contribute directly to a respected manufacturer's product quality, compliance, and operational excellence.
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Responsibilities
• Lead and continuously improve the company's Quality Management System (QMS) • Ensure all products meet customer, technical, and regulatory requirements • Own the Non-Conformance (NCR) process and reporting • Manage CAPA from root cause through verification • Oversee Quality Control functions, including incoming inspection and calibration reporting • Conduct and prepare for internal and external audits, ensuring timely responses to findings • Serve as the site Management Representative for audits and regulatory interaction • Develop and maintain SOPs, work instructions, and QC checklists • Administer the complaint handling system with timely responses • Define quality requirements for new products and projects • Track and present key quality metrics in management review meetings • Promote a culture of quality and continuous improvement
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Qualifications
• Associate or Bachelor's degree in engineering or another technical field is required • 5+ years of combined
Quality Management & Quality Control
with medical devices is required • Experience with
ISO 13485, FDA QSR, and GMP standards
is required • Quality audit experience is required • Proficiency with Electronic Quality Management Systems (eQMS) required
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Description
Our client, a manufacturer serving the medical industry, is seeking a
Quality
Manager
to join their team in Billerica, MA. This role leads a small, collaborative team while remaining hands-on approximately 70% of the time, focused on daily quality activities and 30% on planning, metrics, and reviews. The company recently completed an FDA audit and maintains a well-established Quality Management System focused on continuous improvement. The ideal candidate brings strong experience in
both Quality Management and Quality Control within the medical device industry , with a deep understanding of ISO Quality Systems, FDA, GMP, and QSR requirements. Success in this role requires a leader who enjoys balancing floor-level engagement with strategic oversight in a metric-driven environment. This is a great opportunity to contribute directly to a respected manufacturer's product quality, compliance, and operational excellence.
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Responsibilities
• Lead and continuously improve the company's Quality Management System (QMS) • Ensure all products meet customer, technical, and regulatory requirements • Own the Non-Conformance (NCR) process and reporting • Manage CAPA from root cause through verification • Oversee Quality Control functions, including incoming inspection and calibration reporting • Conduct and prepare for internal and external audits, ensuring timely responses to findings • Serve as the site Management Representative for audits and regulatory interaction • Develop and maintain SOPs, work instructions, and QC checklists • Administer the complaint handling system with timely responses • Define quality requirements for new products and projects • Track and present key quality metrics in management review meetings • Promote a culture of quality and continuous improvement
Quality Manager (5+ Yrs. Medical Device QM & QC Exp. Req.) Qualifications
• Associate or Bachelor's degree in engineering or another technical field is required • 5+ years of combined
Quality Management & Quality Control
with medical devices is required • Experience with
ISO 13485, FDA QSR, and GMP standards
is required • Quality audit experience is required • Proficiency with Electronic Quality Management Systems (eQMS) required