Quality Engineer

7 days ago

Carlsbad, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Lead management of Quality Engineering Deliverables for New Product Development.
  • Lead Supplier Qualification for New Product Development.
  • Support Material Review Board (MRB).
  • Develop inspection methods, cages and associated drawings and procedures.
  • Support Engineering Change Order Review.
  • Perform Design for Manufacturing (DFM).
  • Technical interface with contract manufacturing.
  • Support Design Control to ensure efficient, effective, and compliant new product launches.
  • Support suppliers in performing IQ, OQ and PQ processes.
  • Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
  • Lead Risk Management efforts in accordance with ISO 14971.
  • Perform Failure Mode and Effects Analysis (FMEA) for design and processes.
  • Support validations for sterilization, cleaning and shipping.
  • Participate in FDA, ISO and other regulatory audits.
  • Other duties as assigned.
Requirements:
  • Knowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards.
  • Experience supporting on-market / commercialized products.
  • Knowledge of mechanical inspection methods and equipment.
  • Knowledge of SPC, DOE, probability and statistics.
  • bility to read, analyze, and interpret blueprints and GD&T.
  • bility to solve complex problems to root cause and prevent re-occurrence (CAPA).
  • bility to write reports and procedures.
  • bility to effectively interact with all levels of the organization.
  • bility to develop and maintain strong working relationships with internal and external customers and suppliers.
  • Knowledge of Solid Works or other CAD software.
  • Good decision-making skills and judgment.
  • The ability to execute plans/strategies to completion.
  • Working knowledge of biocompatibility requirements.
  • Must be able to travel up to 10% of the time.
  • Minimum bachelor's degree (BS) from a four-Year College or university in Mechanical, Industrial and Systems, Biomedical, or Manufacturing Engineering.
  • 1-5 years related experience and/ or training; or equivalent combination of education and experience.

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