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Principal Internal Auditor, Quality Systems (Onsite or Hybrid Remote) Request ID: Req-22797 Loc[...]

Company: Edwards Lifesciences
Location: Irvine
Posted on: March 19, 2023

Job Description:

The "Principal Internal Auditor, Quality Systems" will conduct internal audits to ensure the quality system conforms to documented arrangements and regulatory requirements and that is effectively implemented and maintained.Key Responsibilities:

  • Prepare the audit plan, to ensure coverage of applicable regulations, processes, and elements according to the audit schedule.
  • Conduct audits including complex assessments, to ensure conformance with applicable regulations and EW procedures and instruction. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings
  • Assess previous audit findings to establish strategies and evaluate the effectiveness of the actions taken.
  • Conduct opening meetings and closure meetings.
  • Prepare audit documentation including attendance sheets, audit plan and audit report. Ensure documentation is complete, including all objective evidence.
  • Execute audit considering scope to assure efficient and effective use of scheduled time allocations
  • Assist in generating metrics for overall auditing system and identify continuous improvement opportunities; may also present metrics to all level of the organization
  • Other duties assigned by LeadershipMinimum Required Qualifications:
    • Bachelor's Degree with 8 years of quality compliance auditing experience; or Master's Degree with 6 years of quality compliance auditing experience
    • ISO 13485 Certified Lead Auditor
    • Medical device industry experience
    • Experience preparing, conducting, and documenting internal audits
    • In-depth knowledge and working experience with either of these medical device regulations: 21 CFR Part 820, SOR/98/282, RDC 665, MHLW 169, TG 2002, MDSAP, and/or EU MDR 2017/745
    • Excellent written and verbal communication skills including negotiating and relationship management skills
    • Strong problem-solving and critical thinking skillsPreferred Qualifications:
      • Experience with Quality Systems (i.e. CAPAs, NCRs, Complaints, Field Corrective Actions, etc)
      • Experience with Engineering or Quality Operations
      • Ability to manage multiple concurrent auditsAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $106,000 to $151,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Keywords: Edwards Lifesciences, Irvine , Principal Internal Auditor, Quality Systems (Onsite or Hybrid Remote) Request ID: Req-22797 Loc[...], Accounting, Auditing , Irvine, California

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