Quality Control Inspector (Contractor)

Mevion Medical Systems; Littleton (MA); In loco; USD 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Mevion Medical Systems in Littleton, MA seeks a Quality Control Inspector (Contractor) to ensure incoming, in-process, and finished components meet stringent quality standards. The role involves GD&T interpretation, FAI, and extensive documentation to support compliance with FDA/ISO 13485.

As a key member of Manufacturing Engineering, Production, and Quality teams, you will calibrate inspection tools, maintain records, and drive process improvements while safely handling parts up to 20 lbs.

Competenze

• High school diploma or equivalent; associate degree or higher is a plus.
• At least three years of experience in Quality Control; medical device inspections a plus.
• Strong GD&T knowledge and mechanical drawings.
• Proficient with inspection tools (calipers, micrometers, etc.).
• Familiar with ERP systems and internal document control systems.
• Strong attention to detail and ability to work independently.
• Good documenting skills and ability to organize tasks.
• Experience with MS Office (Word, Excel, SharePoint).
• Excellent communication with internal customers.

Mansioni

• Perform dimensional, visual, and functional inspections of components, subassemblies, and finished assemblies.
• Conduct first article inspections (FAI), in-process inspections, and final inspections.
• Document and maintain detailed inspection reports, records, and quality documentation.
• Interpret engineering drawings, GD&T symbols, specifications, and inspection procedures to ensure compliance with requirements.
• Maintain inspection equipment calibration and ensure proper usage of tools.
• Document and process any non-conforming issues found during inspection.
• Support internal and external audits by providing inspection records.
• Support Quality Control and Calibration process improvement projects.
• May need to move and position parts >20 lbs with hoists/lifts.

Conoscenze

GD&T knowledge

Inspection methods

Documentation

Attention to detail

MS Office

Communication

Independent work

Formazione

High school diploma or equivalent

Associate degree or higher preferred

Strumenti

Calipers

Micrometers

Micro-Hite

Pin gauges

Thread gauges

ERP systems

Descrizione del lavoro

Position Summary

The Quality Control Inspector (Contractor) will be responsible for ensuring that incoming, in-process, and finished components meet quality standards. This role requires expertise in inspection methods, familiarity with FDA and ISO 13485 requirements, and the ability to work closely with Manufacturing Engineering, Production, and Quality teams to maintain compliance and product integrity.

Position Summary

The Quality Control Inspector (Contractor) will be responsible for ensuring that incoming, in-process, and finished components meet quality standards. This role requires expertise in inspection methods, familiarity with FDA and ISO 13485 requirements, and the ability to work closely with Manufacturing Engineering, Production, and Quality teams to maintain compliance and product integrity.

Essential Functions

• Perform dimensional, visual, and functional inspections of components, subassemblies, and finished assemblies.
• Conduct first article inspections (FAI), in-process inspections, and final inspections.
• Document and maintain detailed inspection reports, records, and quality documentation.
• Interpret engineering drawings, GD&T symbols, specifications, and inspection procedures to ensure compliance with requirements.
• Maintain inspection equipment calibration and ensure proper usage of tools.
• Document and process any non-conforming issues that are found during inspection.
• Support internal and external audits by providing inspection records.
• Support Quality Control and Calibration process improvement projects.
• May need to move and position parts greater than 20 lbs with the use of hoists and/or lifts.

Education, Training, And Experience

• A high school diploma or equivalent. An associate degree or higher is a plus.
• At least three (3) years of experience in Quality Control. Medical device inspections experience a plus.
• Strong knowledge of GD&T (Geometric Dimensioning & Tolerancing) and mechanical drawings.
• Proficient in the use of inspection tools such as Calipers, Micrometers, Micro-hite, Pin gages, Thread gages, etc.
• Familiar with the use of ERP systems and internal document control systems.
• Strong attention to detail, organizational skills, and ability to work independently in a fast-paced environment.
• Good documenting skills and ability to organize work tasks.
• Experience in using MS Office tools like Word, Excel, SharePoint, etc.
• Excellent communication skills and be able to interact with internal customers effectively.

Physical And Environmental Considerations

• Must be able to sit/stand for long periods of time.
• Required use of standard office equipment, including laptop, phone, copier, etc.
• Typical office environment.
• Must be able to walk through the factory environment safely.
• The employee will work in high magnetic fields, with high voltages, and with radiation and radioactive materials. The employee may be involved in light rigging operations.
• Must be able to lift up to 20 pounds.

The hiring range represents what Mevion Medical Systems, Inc. reasonably expects to pay for this position at the time of posting. The actual salary offered will depend on the selected candidate’s qualifications, experience, skills, and other job-related factors.