Manufacturing Quality Assurance

3 weeks ago

Woburn, United States TalentBurst Full time
Title: Manufacturing Quality Assurance
Location: Woburn, MA
Duration: 12+ Months

Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which is utilized in sample preparation processes in the analytical and life sciences industries worldwide.

Summary:
We are seeking a Quality Assurance Contractor to join our team for 9 t0 12 months. The Quality Assurance Contractor will play a key role in implementing an efficient ISO-13485 / IVDR compliant environment. Initial primary focus will be on supply chain related processes including purchasing, supplier controls, nonconformance and incoming inspection processes.
The Quality Engineer will report directly to the Director of QA/RA. High level of independent activity is expected. Position is majority of time on site.
  • Purchasing Process:
    • Understand and improve purchasing process as it pertains to manufacturing. Whereas this connects to the Change Order process, it extends into the ERP and Salesforce.
    • Understand and resolve existing pain-points, both through direct application of resource and through preventive process improvements
  • Supplier Management Process:
    • Re-establish Approved Supplier List and associated records
    • Integrate Supplier Management Process with Purchasing and Change Order Processes
  • Supply chain and incoming inspection
    • Develop and implement supply chain process improvement
    • Drive true root cause analyses in support of Nonconformance process, implement continuous improvement to product and process
Continuous Improvement:
  • Lead and manage quality initiatives in multiple areas of product and processes quality. Ensure successful, on-time completion of continuous improvement projects,
  • Escalate potential issues that could impact compliance, reliability, cost and quality.
  • Perform other duties as assigned
Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.
  • Establish and maintain approved supplier list.
  • Administer and improve Quality processes, with focus on Lean process management
Non-Essential Responsibilities: The employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
Qualifications:
  • Bachelor's degree (minimum) in an Engineering, Technical or Scientific discipline or equivalent.
  • Pragmatic, entrepreneurial personality and strong self-starter. Always strives to improve
  • Minimum of 2+ years of working experience in Quality Assurance in regulated (e.g. IVD, Medical Device, Automotive, etc.) environment.
  • Deep understanding of purchasing and supplier management processes
  • Understand Design Controls, Change Controls, Product, and Engineering Processes.
  • Proficient in Statistical Process Controls & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
  • Communicates effectively both verbally and in writing
  • Acts decisively with Integrity and Kindness.
#TB_PH

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