#twiceasnice Recruiting
Quality Manager (5+ Yrs Medical Device QM & QC Exp Req, $135K-$150K)
#twiceasnice Recruiting, Waltham, Massachusetts, United States, 02254
Overview
Quality Manager with 5+ years in medical device QM & QC, located in Billerica, MA. Leads a small, collaborative team and remains hands-on approximately 70% of the time (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 has strong experience in both Quality Management and Quality Control within the medical device industry, with knowledge of ISO quality systems, FDA, GMP, and QSR requirements. This role balances floor-level engagement with strategic oversight in a metric-driven environment, and contributes to product quality, compliance, and operational excellence. Details
Salary:
$135,000 - $150,000 + Benefits 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 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. Qualifications
Associate or Bachelor’s degree in engineering or another technical field. 5+ years of combined Quality Management & Quality Control in medical devices. Experience with ISO 13485, FDA QSR, and GMP standards. Quality audit experience. Proficiency with Electronic Quality Management Systems (eQMS). Company and Location
Our client, a manufacturer serving the medical industry, is seeking a Quality Manager to join their team in Billerica, MA.
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Quality Manager with 5+ years in medical device QM & QC, located in Billerica, MA. Leads a small, collaborative team and remains hands-on approximately 70% of the time (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 has strong experience in both Quality Management and Quality Control within the medical device industry, with knowledge of ISO quality systems, FDA, GMP, and QSR requirements. This role balances floor-level engagement with strategic oversight in a metric-driven environment, and contributes to product quality, compliance, and operational excellence. Details
Salary:
$135,000 - $150,000 + Benefits 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 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. Qualifications
Associate or Bachelor’s degree in engineering or another technical field. 5+ years of combined Quality Management & Quality Control in medical devices. Experience with ISO 13485, FDA QSR, and GMP standards. Quality audit experience. Proficiency with Electronic Quality Management Systems (eQMS). Company and Location
Our client, a manufacturer serving the medical industry, is seeking a Quality Manager to join their team in Billerica, MA.
#J-18808-Ljbffr