Ensure compliance of the QMS and compliance within quality processes (e.g., CAPA. NCR, ECR, internal and external auditing, training). Maintain quality reporting inclusive quality and production indicators.
**Key Responsibilities**:
- Provide complex assessments including audits to ensure conformance with applicable regulations and EW policies and procedures. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings
- Provide technical guidance and lead projects, based on understanding of international standards and regulations, to business unit and/or corporate quality initiatives including special projects, such as designing and/or recommending systems, procedures, etc.
- Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, allocate time, and schedule meetings. Assess previous audit findings to establish priorities and strategies
- Execute audit considering scope to assure efficient and effective use of scheduled time allocations
- Identify, lead and implement business process improvement solutions for Quality Systems, including developing changes to procedures, to improve operation, efficiencies, and user experience, while supporting the integrity of the business process. Local process owner for quality system processes (e.g., CAPA, NCR, internal auditing, risk management)
- Provide teams first-level support to Quality, Documentation and PCS Systems users, e.g., CAPA, NCR, Change, Training, Maintenance, for system usage and process requirements
- Recommend changes to documentation associated with Quality, Documentation and PCS Systems, including assessing effectiveness and approving recommendations others
- Identify continuous improvement opportunities including performing complex analysis and may present metrics to all level of the organization
- Train, coach, and guide lower level employees on more complex procedures
- Other incidental duties
**Education and Experience**:
Bachelor's Degree in Engineering or Scientific field, 6 years of experience minimum, including either industry or industry/education Required or
Master's Degree or equivalent in Engineering or Scientific field, 5 years of experience minimum, including either industry or industry/education Required or
Ph.D. or equivalent in Engineering or Scientific field, 2 years of experience minimum, including either industry or industry/education Required.
**Additional Skills**:
- Proven expertise in MS Office Suite and experience with quality systems (e.g., CAPA, Ignite)
- Experienced in GxP
- Good project management skills and related software tools preferred
- Excellent written and verbal communication skills including influencing and relationship management skills
- Strong problem-solving and critical thinking skills
- Ability to read, comprehend, write and speak English fluently, required
- Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
- Excellent knowledge of medical or pharmaceutical regulations as relating to documentation
- Excellent understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485, ISO14971, and MDD)
- Strict attention to detail
- Ability to interact professionally with all organizational levels across sites
- Ability to manage competing priorities in a fast-paced environment
- Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on projects and for compliance topics
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 18,500 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
**For United States Applicants Only**:
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