Quality Control Inspector

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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 13485orISO 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 dev...