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Quality Engineer - Medical Device

  • Job type: Permanent
  • Location: Allen
  • Salary: Competitive
  • Job reference: MERZ031020181244
  • Sector: EPM Scientific, Quality
  • Date posted: 10/03/2018
  • Medical Device Company – Cardiac Surgery, Oncology, Anesthesia Delivery, IV Fluid
  • Texas
  • $75,000 - $95,000 + Bonus + Benefits + Excellent Career Growth
A global medical device company is looking to hire a QUALITY ENGINEER to join the team! This company is one of the leaders committed to manufacturing, developing, and distributing sterile medical devices. They have a great vision and focus on Cardiac Surgery, Oncology, Anesthesia Delivery, & IV Fluid. This company is family oriented, has a great work-life culture, and has been expanding in size! They offer a competitive base salary, bonus, benefits, and professional career growth!

The QUALITY ENGINEER will have the responsibility for improving and maintaining the Quality Management System. This individual will perform activities to support quality aspects – development, design, manufacture, and post-production of components and finished products. Leadership and support will be provided to teams focusing on CAPA. This is in correlation to conducting CAPA activities to investigate non-conformances and determining root cause analysis. Support will be provided to the supplier quality program by conducting audits, managing supplier corrective action plans, and managing supplier metrics.

The QUALITY ENGINEER will be responsible for the following activities:
  • Work closely with Quality Assurance to support NCMR and CAPA processes
  • Provide guidance and leadership to investigation team members to ensure the timely completion of NCMRs and CAPAs
  • Work cross-functionally with Operations, Project Management, and Subject Matter experts in support of the Design Control process
  • Represent Quality Systems functions during regulatory, internal and third party audits
  • Provide quality oversight of product development documentation and tasks required in order to satisfy risk management and design controls in accordance with established SOPs
  • Review and approve Risk Management documents, Validation and Verification processes and documentation
The QUALITY ENGINEER will have the minimum requirements:
  • Knowledge of medical device design and process controls per ISO 13485 and FDA Quality System Requirements
  • Bachelor’s degree in Quality Engineering, Engineering, or Sciences
  • 5+ years experience in Manufacturing/Engineering or Quality Assurance environment
  • Previous design experience
  • Expertise in risk management and auditing, design controls, and product investigations
  • Strong communication, organizational and leadership skills
  • Must be team oriented
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