Quality Control Inspector

Description

Are you a Quality Control Inspector looking to join one of the top companies in the Manufacturing industry?

Are you looking to further your career and grow?

Do you have experience operating under ISO 13485 or ISO 9001 quality systems
?

If you answered yes to those three questions, then apply today!

Acara Solutions seeks highly qualified candidates to work onsite with our client in Newton, MA. Interested?

• 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.
• 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 needed.
• 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.

Pay: $50.00/hr.

Hours:

40 hours/week - 1st shift.

Length:
Temp (12 months).

Applicants must be legally authorized to work in the United States.

This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

• High School Diploma or GED.
• Minimum of 4 years of experience operating under ISO 13485 or ISO 9001 quality systems.
• Medical device manufacturing environment.
• Proficiency in Good Documentation Practices (GDP) and controlled environment requirements for sterile consumables.
• Experience with Coordinate Measurement Machines (CMM) - tactile and vision-based.
• Certified Mechanical Inspector.
• 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.
• Familiarity with ERP systems for tracking components and consumables (SAP experience).
• Strong working knowledge of Microsoft Office, especially Excel, for data entry and analysis.
• High attention to detail, particularly in maintaining traceability and sterility document.

• Upon offer of employment, the individual will be subject to a background check and a drug screen.
• In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the necessary employment eligibility verification form upon hire.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Talent Rise, Viaduct) are an Equal Opportunity Employer. Race/Color/Gender/Religion/National Origin/Disability/Veteran.

APPLY TODAY