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Senior Quality Control Inspector (Medical Device Manufacturing)
Senior Quality Control Inspector (Medical Device Manufacturing)BlackStar • Littleton, MA, US
Senior Quality Control Inspector (Medical Device Manufacturing)

Senior Quality Control Inspector (Medical Device Manufacturing)

BlackStar • Littleton, MA, US
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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
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