Senior Quality Control Inspector - Medical Devices

Job Description

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