Senior Quality Control Inspector

About the Role

We are seeking a Senior Quality Control Inspector to join our team in Littleton MA. This role plays a critical part in ensuring our products meet the highest standards of quality and regulatory compliance. You will perform detailed mechanical inspections maintain adherence to FDA and ISO 13485 requirements and collaborate across departments to uphold quality and product integrity throughout the manufacturing process.

Key Responsibilities

• Conduct dimensional visual and functional inspections of components subassemblies and final products.
• Perform First Article (FAI) in-process final and RMA inspections to ensure compliance with specifications.
• Maintain and calibrate inspection equipment in the Quality Control Lab; support internal calibration activities.
• Create and manage part-specific inspection forms quality records and documentation.
• Support R&D and new product development through inspection and verification activities.
• Interpret engineering drawings specifications and GD&T symbols to verify product conformance.
• Record and process non-conformances participate in root cause investigations and support corrective actions.
• Prepare inspection data for internal and external audits.
• Collaborate with suppliers to obtain technical information and verify product quality.
• Participate in continuous improvement initiatives to enhance accuracy efficiency and compliance.

Must-Have Qualifications

• High School Diploma or equivalent (associate or bachelors degree preferred).
• Minimum 7 years of Quality Control experience ideally in the medical device industry.
• Strong background in mechanical inspection calibration and metrology.
• Proficiency in GD&T interpretation and reading mechanical/engineering drawings.
• 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).
• Working knowledge of FDA regulations ISO 13485 standards and IPC inspection standards.

Preferred Qualifications

• Experience in medium-sized medical device manufacturing environments (100200 employees).
• Hands-on experience with eQMS platforms such as Ketryx SimplerQMS QT9 QMS Kivo or Qualio (35 years preferred).
• Certifications such as ISO 13485 Lead Auditor Certified Medical Device Compliance Professional (CMDCP) or Certified Medical Device Quality Auditor.
• Strong record of career stability and long-term contribution in previous quality control roles.
• Familiarity with root cause analysis and continuous improvement methodologies.
• Leadership or mentoring experience is a plus but not required.

Benefits

• Competitive compensation package
• Comprehensive health dental and vision insurance
• Paid time off and holidays
• 401(k) plan with company match
• Opportunities for career development and professional growth