Job description

**The work location for this position will be Irvine, CA and this role is not eligible to be 100% remote. But there is flexibility to work remote one day per week**

This Senior Quality Assurance GLP 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 GLP in-life phase and final report audits including complex assessments, to ensure conformance with applicable regulations, standards, and Edwards’ policies and procedures
Evaluate the appropriateness and effectiveness of corrective actions
Review GLP protocols, surface area calculations based on drawings, and GLP associated SOPs
Execute process and system/facility audits on an annual basis, establish audit content, allocate time, and schedule meetings
Assess previous audit findings to establish priorities and strategies
Provide input and may lead projects, based on understanding of standards and regulations, to business unit and/or corporate quality initiatives including special projects
Provide training, guidance, and coaching to junior 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
Perform supplier audits for contract testing laboratories
Other duties assigned by management

Minimum Required Qualifications (Must Have):
Bachelor’s Degree with 5 years of quality auditing experience; or Master’s Degree with 3 years of quality auditing experience
Medical device and/or pharmaceutical experience
Experience in auditing against 21 CFR Part 58

Preferred Qualifications (Nice to Have):
Degree in science or engineering field
Full knowledge and understanding of 21 CFR Part 58 and ISO 10993-Parts 1-12
Ability to manage multiple concurrent audits/reviews
Strict attention to detail
Ability to manage competing priorities in a fast-paced environment
Excellent written and verbal communication skills
Strong problem-solving and critical thinking skills
Ability to interact professionally with all organizational levels and be a team player
Ability to interact with senior personnel on significant matters often requiring coordination between departments
Knowledge in performing biocompatibility test method verification and equipment validation audits
Proven expertise in MS Office Suite and ability to operate general office machinery
Ability to travel, as applicable

About Edwards Lifesciences

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 13,000 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.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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