Senior Quality Control Inspector (Medical Device Manufacturing)

Job Description

We are seeking a Senior Quality Control Inspector to join our growing team in Littleton, MA. In this hands-on role, you will perform precise mechanical inspections to ensure our products meet the highest standards of quality and compliance. You will work closely with cross-functional teams, supporting manufacturing and R&D processes while maintaining adherence to FDA and ISO 13485 requirements.

If you have a passion for precision, attention to detail, and experience in medical device inspection, this is an excellent opportunity to advance your career in a dynamic and collaborative environment.

Key Responsibilities:

Perform dimensional, visual, and functional inspections of components, subassemblies, and finished products.

Conduct First Article Inspections (FAI), in-process, final, and RMA inspections.

Maintain and calibrate inspection equipment within the Quality Control Lab; assist with internal calibrations.

Create and maintain part-specific inspection forms and quality documentation.

Support R&D projects and new product development with inspection expertise.

Interpret engineering drawings, specifications, and GD&T to ensure product compliance.

Document and process non-conformances, and assist with root cause investigations.

Prepare inspection records for internal and external audits.

Collaborate with suppliers for product verification and technical clarification.

Participate in continuous improvement initiatives to enhance inspection accuracy and efficiency.

Qualifications:

Required:

High school diploma or equivalent (Technical degree a plus)

7+ years of Quality Control inspection experience in a manufacturing environment (medical device preferred)

Strong knowledge of mechanical inspection, metrology, and calibration processes

Proficient in reading engineering drawings and interpreting GD&T symbols

Skilled in using inspection tools such as calipers, micrometers, microhite, pin gages, and thread gages

Experience with ERP/MRP systems and electronic Quality Management Systems (eQMS)

Familiarity with IPC standards for inspection

Benefits:

Competitive salary based on experience

Comprehensive health, dental, and vision insurance

Paid time off (PTO) and paid holidays

401(k) plan with company match

Professional development and career advancement opportunities

Full-time