Edwards Lifesciences Veterans Jobs

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Edwards Lifesciences Quality Compliance Auditor in Shannon, Ireland

The Company: Edwards Lifesciences is 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.

The Role: Conduct internal policy and procedure audits to ensure conformance with international quality system and Good Laboratory Practices standards, including leading SME teams, and establishing and executing auditing schedules

Key Responsibilities:

• Conduct audits including complex assessments, 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

• 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

• Develop audit process findings, and may have input to improve process flow for compliance, and evaluate the effectiveness of previous corrective actions

• Provide input and may 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

• Evaluate the appropriateness and effectiveness of corrective actions

• Provide training, guidance, and coaching to team members

• 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

• Assist in Regulatory Audits Lead efforts to prepare the site for Regulatory Audits. Provide training on audit best practices. Act as Internal Auditor SME

• Other duties assigned by Leadership

Education and Experience:

Bachelor's Degree in related field, 5 Years years experience Quality Compliance Auditing Required and

pharmaceutical or medical device industry Preferred

Certification years experience Professional Audit Designation required

Additional Skills:

• Ability to manage multiple concurrent audits

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

• Excellent written and verbal communication skills including negotiating and relationship management skills

• Excellent problem-solving, organizational, analytical and critical thinking skills

• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance auditing

• Full knowledge of [ISO13485/QSR/MDSAP]

• Good leadership skills and ability to influence change

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• 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 contracts or projects

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

• Adhere to all EHS rules and requirements 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

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.

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