Quality Manager - Medical Devices | Hands-On Leader

#twiceasnice Recruiting; Boston (MA); On-site; USD 135,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A recruiting firm in Billerica, MA is seeking a Quality Manager with over 5 years of experience in Quality Management and Quality Control for the medical device industry. This role involves leading the Quality Management System, ensuring compliance with regulations, and managing quality metrics. Ideal candidates will have experience in ISO 13485 and FDA QSR standards, along with a solid understanding of quality auditing. Competitive salary of $135K-$150K and benefits included.

Qualifications

• 5+ years of combined Quality Management & Quality Control experience with medical devices.
• Experience with ISO 13485, FDA QSR, and GMP standards.
• Quality audit experience is required.

Responsibilities

• Lead the Quality Management System (QMS).
• Ensure products meet customer and regulatory requirements.
• Manage Non-Conformance (NCR) processes.

Skills

Quality Management

Quality Control

ISO 13485

FDA QSR

GMP standards

Electronic Quality Management Systems (eQMS)

Quality Auditing

Education

Associate or Bachelor’s degree in engineering or technical field

Job description

A recruiting firm in Billerica, MA is seeking a Quality Manager with over 5 years of experience in Quality Management and Quality Control for the medical device industry. This role involves leading the Quality Management System, ensuring compliance with regulations, and managing quality metrics. Ideal candidates will have experience in ISO 13485 and FDA QSR standards, along with a solid understanding of quality auditing. Competitive salary of $135K-$150K and benefits included.