Quality Assurance Inspector
Share
Job Location:
Newton, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Description:
Position Summary: 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 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 docum
Enable Skills-Based Hiring No 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 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 docum
| Vaccination Notice |
Additional Details
- Does this worker qualify for overtime : Yes
- Scorecard Category : Light Industrial
- Commercial Title : Sr. Quality Assurance Inspector
- Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption.
- Is this position for a pre-identified (PAYROLLED) candidate : RECRUITED
- If this is a pre-identified (PAYROLLED) candidate please see note below and provide the following: : N/A
- Will this contingent worker require a computer or systems access or utilize a timeclock : Yes
- Time System : Fieldglass
- Timeclock/Shift : Fieldglass1
- Enter Shift Start and End Time : 8:30 AM-5:00 PM
- Is there potential for this to convert to a full time position : Yes
- Non-Employee Class : Temporary Agency Worker
- Will the worker be required to travel for client : No
- Is there potential for this assignment to be extended beyond 13 weeks : Yes
- Type of assignment : Full-time
- Will this position require a DEA background check clearance : No
- Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start not applicable in the following states: Alabama Florida Iowa Kansas Montana North Dakota Tennessee Texas and Utah. States subject to change
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- Coordinate Measuring Machine
- GD&T
- ISO 9001
- Dimensional Inspection
- Micrometer
- Quality Control
- QA/QC
- As9100
- Manufacturing
