Quality Control Inspector

Title: Quality Control Inspector

Location: Newton, Massachusetts

JD:

The Quality Control Inspector is responsible for ensuring that electromechanical components and single-use sterile consumable components and assemblies comply with company and regulatory standards. Key responsibilities include inspecting mechanical, electrical (including PCB/PCBA) and single-use consumable components and assemblies, while maintaining accurate quality documentation. The role also supports compliance with an ISO 13485–certified quality management system and contributes to safeguarding product quality, patient safety, and continuous improvement in the manufacturing process.

Primary Responsibilities: 

• Perform incoming part inspections with emphasis on electromechanical components and sterile single use consumable components.

• Conduct in-process inspections of assemblies to ensure compliance with design and sterile-use requirements.

• Inspect subassemblies and finished products, including single-use sterile consumables, for conformance to specifications.

• Generate and manage Nonconformance Reports (NCMRs) as required.

• Generate, review and maintain inspection records and reports in accordance with Good Documentation Practices (GDP).

• Review and maintain Part/Device History Records (DHRs), ensuring traceability of sterile consumables and electromechanical assemblies.

• Support continuous improvement, part investigations, and compliance initiatives across electromechanical and sterile consumable workflows

• Support Test Method Validation (TMV) (i.e., Gage R&R Studies) and Inspection Method development activities.

• Perform other quality-related duties as assigned by management.

Key Requirements:

• Demonstrated experience operating under ISO 13485 or ISO 9001(or equivalent) quality systems (medical device manufacturing environment preferred).

• Proficiency in Good Documentation Practices (GDP) and controlled environment requirements for sterile consumables.

• Experience with Coordinate Measurement Machines (CMM) – tactile and vision-based, strongly preferred.

• Certified Mechanical Inspector (or equivalent) preferred

• Familiarity with applicable standards: ANSI, ASTM, MIL, IEC test methods.

• Skilled in the use of precision hand tools for mechanical and electrical inspection.

• Proficiency with optical comparators and vision measurement systems (e.g., Micro-Vu).

• Ability to measure and verify geometric tolerances in precision electromechanical and consumable parts.

• Competence in interpreting wiring diagrams and PCB schematics for electromechanical devices.

• Prior experience in PCB/PCBA inspection and IPC 610 methods strongly preferred.

• Familiarity with ERP systems for tracking components and consumables (SAP experience is strongly preferred).

• Strong working knowledge of Microsoft Office, especially Excel, for data entry and analysis.

• High attention to detail, particularly in maintaining traceability and sterility documentation.

• Ability to work overtime.