Edwards Lifesciences Veterans Jobs

Job Information

Edwards Lifesciences Senior Quality Compliance Auditing Specialist - GLP/Non Clinical Study Audits (Corporate Quality) in Irvine, California

The Sr. Quality Compliance Auditing Specialist will be responsible for conducting internal and external non-clinical audits ( in-vitro and in-vivo ) on safety and biocompatibility studies to ensure conformance to 21 CFR Part 58 (Good Laboratory Practice for Non-Clinical Laboratory Studies), ISO standards, and SOPs.

Key Responsibilities:

  • Conduct audits including complex assessments, to ensure conformance with applicable regulations and Edwards policies and procedures

  • Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of non-conformance findings

  • Provide input and may lead projects, based on understanding of standards and regulations, to business unit and/or corporate quality initiatives including special projects

  • Evaluate the appropriateness and effectiveness of corrective actions

  • Review GLP protocols, raw data, and final reports

  • Execute annual audit schedule, establish audit content, allocate time, and schedule meetings

  • Assess previous audit findings to establish priorities and strategies

  • Provide training, guidance, and coaching to team members

  • 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 management

Education & Required Qualifications:

  • Bachelor’s Degree or equivalent in science or engineering fields

  • Minimum of 5 years’ experience as a Quality Auditor

  • Required medical device and/or pharmaceutical experience

  • Experience in auditing against 21 CFR Part 58

Preferred Qualifications:

  • Ability to manage multiple concurrent audits/reviews

  • Full knowledge and understanding of 21 CFR Part 58 and ISO 10993-Parts 1-12

  • Test Method Validations and Equipment Validations (e.g. IQ/OQ/PQ)

  • Test Method Verifications

  • Strict attention to detail

  • Excellent written and verbal communication skills

  • Strong problem-solving and critical thinking skills

  • Ability to manage competing priorities in a fast-paced environment

  • Ability to interact professionally with all organizational levels and be a team player

  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

  • Proven expertise in MS Office Suite and ability to operate general office machinery

  • Ability to travel, as applicable

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.