Senior Quality Assurance Inspector

Are you a Senior Quality Assurance Inspector who is looking to join one of the top companies within the Manufacturing Industry?

Are you looking to further your career and grow?

Do you have experience in operating under ISO 13485 or ISO 9001(or equivalent) quality systems?

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

Acara Solutions is seeking highly qualified candidates to work ON-SITE with our client in Newton, MA. Interested?

Here's what you'd do:

• 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.

Here's what you'll get:

Pay: $50.00/ hr.

Hours: 40 hrs/Week (1^st shift)

Length: Temp (6 Months)

Sound like a good fit?

APPLY TODAY

About Acara Solutions

Acara is a premier provider of recruiting and workforce solutions-we help companies compete for talent. With a legacy of experience in a variety of industries around the world, we partner with clients, listen to their needs, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

• High School Diploma or GED
• Minimum of 2 years experience in operating under ISO 13485 or ISO 9001(or equivalent) 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 docum

Additional Information: