Quality Systems Engineer/Lead Auditor
Orchid Orthopedic Solutions, LLC - Arcadia, CA

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Summary: Develop and analyze Quality Systems procedures and documents to ensure that quality systems are managed and maintained in accordance to Corporate Policy, good quality practice and compliance with SIO 9001 / ISO 13485 and FDA (21 CFR 820) standards.. Create training for revised documents. Work with Suppliers to make sure they meet or exceed ISO and FDA requirements for medical device manufacturing. Work with Customers to assure that Orchid supplies product which meets their requirements.

Major Duties & Activities Required by the Position:
  • Ensure our quality system stays ISO 9001 / ISO 13485 and FDA 21 CFR 820 certified
  • Ensure controlled documents are up-to-date
  • Coordinate employee training and ensure it is complete
  • Work on continuous improvement of processes and quality
  • Conduct plant surveillance audits
  • Work with suppliers on quality improvement and process improvement
  • Assist Quality Assurance Manager in customer, ISO and FDA audits
  • Conduct internal audits for ISO 13485:2003 on a periodic basis
  • Corrective Action Preventative Action (CAPA)
  • Ability to handle customer complaints and returns
  • Monitor Customer Scorecards and management improvement initiates
  • Maintain production history by DHR
  • Determine and Monitor Quality Metrics and prepare quality reviews and reports
  • Conduct quality improvements using tools of Six Sigma and Lean Manufacturing
  • Ability to conduct benchmarking for department
  • Provide Environmental Health & Safety (EHS) support for the plant
  • Support Validation initiatives and be able to conduct IQ/OQ/PQ support
  • Provide support for information and training
Preferred Qualifications Include:
  • High level of critical thinking and problem solving aptitude
  • Excellent oral and written communication skills
  • Strong knowledge of ISO 13485 certification requirements
Experience and Education:
  • Preferred College technical degree or equivalent
  • 2 - 5 years of quality experience in a manufacturing environment
  • Prior experience working in a medical device manufacturing facility preferred.
Physical Requirements
  • Negligible

Orchid Orthopedic Solutions, LLC - 17 months ago - save job - block
About this company
Orchid Orthopedic Solutions, LLC acquires MACDEE, a provider of precision machined and molded plastic products to the medical and industrial...