Quality Engineer

2 weeks ago

Franklin, MA, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • The Quality Engineer is the Quality point of contact for strategic customers, for customer driven actions & requests, and Quality Engineering support.
  • Conduct and complete Product Verification Reports (PVR) (i.e. customer PPAPs) for new production introduction (NPI) and customer engineering changes.
  • Investigate product complaints and reported quality issues through PDCA and 8D to ensure closure in accordance with company guidelines and external regulatory requirements and customer expectations.
  • Maintain Corrective and Preventative Action (CPAR) process to ensure Root Cause Analysis (RCA) and identified solution is in place and effective for internal, external, and regulatory reported findings.
  • Monitor and ensure Supplier Corrective Action Reports (SCAR) are effective and resolved in a timely manner.
  • Use and create problem logs to identify and report recurring issues to management and product development teams to drive continuous improvement.
  • Facility customer quality action list to collect, analyze, and summarize data leading to continuous improvement of Company and Customer quality.
  • Implement methods to inspect, test and evaluate the reliability of product quality.
  • Collaborate with Department Managers to maintain, create, & revise QMS documentation as necessary to maintain ISO 9001 registration.
  • Working in accordance with deadlines and priorities for delivery and customer driven actions to required dates.
  • Conduct Internal Audits to ISO 9001:2015 standards.
  • Complete and support customer compliance requests for regulatory compliance (i.e. Rohs & REACH).
  • Participate in MRB meetings and product dispositions.
  • ssist Quality Management in tracking, documenting, and reporting quality levels to meet Quality, CSR (corporate social responsibility), environmental, and health and safety goals/KPIs.
  • Provide cross-functional Quality Engineering support for all I Automation facilities as needed.
Requirements:
  • Requires a bachelor's degree in engineering (i.e. mechanical, chemical, or industrial).
  • 5+ years of professional experience in Quality Engineering.
  • Strong understanding of ISO 9001 standard requirements.
  • Corrective and Preventative Action (CPAR).
  • Root Cause Analysis and 8D.
  • QMS documentation.
  • Investigate product complaints.
  • Product Verification Reports (PVR).
  • Internal Audits to ISO 9001:2015 standards.

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