Quality Compliance Auditor (Hybrid)

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

As the Quality Compliance Auditor you will 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

This is a Hybrid position (3 days on site per week), working hours are 8am-4:30pm (Mon-Thurs), 8am-3:30pm (Friday)
Key Responsibilities:

• Conduct 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

• Evaluate the appropriateness and effectiveness of corrective actions

• Provide input, 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 basic audit considering scope to assure efficient and effective use of scheduled time allocations

• Assist in generating metrics for overall auditing system

• Other duties assigned by Leadership

Education and Experience:

• Bachelor's Degree in related field, 3 Years experience in Quality Compliance Auditing required Required

• Pharmaceutical or medical device industry Preferred

Additional Skills:

• Ability to manage multiple concurrent audits

• Solid computer skills in MS Office Suite and ability to operate general office machinery

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

• Good problem-solving and critical thinking skills

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

• Solid understanding of regulations

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

• Ability to build productive internal/external working relationships

• 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