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.
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
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.