Make a meaningful difference to patients around the world.
Our Manufacturing teams at Edwards Lifesciences facilities worldwide create tools, technologies, and devices that transform patients' lives.
About this role
As a Quality Compliance Auditor on 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 have lasting and positive impacts on patient lives.
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.
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.
* 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.