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Quality Engineer II

Company: Diality
Location: Irvine
Posted on: November 11, 2019

Job Description:

Overall Purpose: This position aligns with Diality's existing organizational chart growth plan. The intent of this position is to support key activities within the Quality function focused on the following:

  • Product inspection and associated infrastructure (Receiving, WIP, final)
  • Supplier management
  • Quality Systems support (processes, auditing, QMS + PLM software administration)
  • Project-specific Quality responsibilities during Design V&V, Design Transfer, and Post-production Duties & Responsibilities:
    • Support implementation, maintenance, and improvement of Quality System processes and procedures.
    • Support Design Control activities for existing medical device products/projects.
    • Provides input regarding appropriate statistical methods and test methodologies.
    • Coordinate investigation of product failures from complaints, CAPAs, Design Verification/Validation deviations, NCMRs, and other quality-related investigations.
    • Support all sustaining quality activities related to Receiving Inspection, In-process Inspection, Supplier Management, Contract Manufacturing, and field non-conformances.
    • Manage Supplier Corrective Action Requests (SCARs) by leading and participating in teams to investigate, analyze, correct and drive corrective action for supplier related nonconformances. Communicate effectively with suppliers regarding SCARs and other quality issues. Evaluate impact of supplier change requests; lead cross-functional teams to identify and execute appropriate actions. Qualification Requirements:
      • Demonstrated experience as a Quality Engineer or equivalent role within a regulated industry (medical device preferred).
      • Demonstrated knowledge of medical device manufacturing processes (GMP), Product inspections, non-conforming material resolution, CAPA, and record keeping.
      • Demonstrated experience with internal and supplier auditing, process validation, metrology, and inspection equipment.
      • Bachelor's in Engineering or Scientific field with a minimum 5 years of experience required.
      • Medical device experience; or experience in a regulated environment.
      • Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint, and Visio) Knowledge & Abilities:
        • Strong understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820 regulatory standards.
        • Strong knowledge and understanding of principles, theories, and concepts relevant to Quality Engineering, including statistical techniques.
        • Flexibility and strong organizational skills with ability to prioritize multiple tasks.
        • Ability to work as a collaborative team member as well as independently.
        • Prior experience with electronic QMS, PLM, ERP systems preferred. Working Environment: This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Travel: Ability to occasionally travel domestically.

Keywords: Diality, Irvine , Quality Engineer II, Engineering , Irvine, California

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