Quality Engineer

1 week ago


Sunnyvale, California, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Identify, document, and track hardware defects and issues using appropriate tools and methodologies.
  • Perform root cause analysis of hardware defects and propose effective solutions to prevent recurrence.
  • Continuously improve and streamline the quality assurance processes and methodologies to enhance efficiency and effectiveness.
  • nd approval of ECO (Engineering Change Orders), (EDA) Engineering Deviation Authorization, and EDA Extensions.
  • Support PSE (Product Support Engineer) Team in conducting RCCM (Root Cause-Counter Measures) for failed parts/spares in the field.
  • Support the (RI) Receiving Inspection Team by developing both FA (First Article) and (IP) Inspection Plans by uploading these approved plans into SAP.
  • Support the CAPA (Corrective Action Preventive Action) Team when required.
  • Participate in internal audits / on-site supplier quality audits and supplier visits to continually monitor supplier capability and compliance when required.
  • Support the Revision of (WI) Work Instructions, (OP) Operating Procedures as required.
  • Maintain a safe work environment and utilize appropriate safety equipment.
  • Maintain internal quarantine parts/spares until the necessary inspection of those materials have been completed and approval given for transfer to the warehouse prior to manufacturing.
Requirements:
  • 3-7 years of experience (manager does not want someone too senior).
  • Background in manufacturing and working with MES systems.
  • Experience in working in a manufacturing/quality environment that involved some type of physical hardware component (for example, not chemicals).
  • Experience directly with ISO 9001.
  • Experience with SAP (required).
  • Experience with Oracle Cloud PLM (plus skill).
  • SAP Quality Module (plus skill).
  • Experience working in a medical devices or life sciences space.
  • Experience with ISO 13485 (specific to life sciences/med devices industry).

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