Manager, EQL Audit (Critical Care)

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.

If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.  

Appendix:  

On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX).  It remains business as usual at Edwards until the transaction closes.  More information on Edwards’ announcement about the acquisition can be found here: https://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bd

Manage the complaint handling process and assure that all best practices, SOP's and procedures related to complaint handling and vigilance are followed by all members in the team and in compliance with applicable regulations.

How You'll Make An Impact:

• Work as contact and support role for all stakeholders related to the complaint process by:

• Spread and help increase the knowledge, skills, and competences in the team.

• Provide support ensuring files are completed on time and to specification.

• Commits time and effort to coach others in new processes or techniques

• Promote effective cross-functional teamwork among team members, including both internal and external stakeholders.

• Lead projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on teams with the support of the manager.

• Identify and lead the implementation of business process improvement solutions for Quality Compliance processes and systems, including interpreting local post market regulation requirements, developing changes to procedures, to improve operation, efficiencies, and user experience, while supporting the integrity of the business process. Local process owner for quality compliance processes and systems. Generate metrics and draw inferences for improvement opportunities and needs.

• Determine new training and training program improvement needs and delivers training to ensure complaint handling requirements can be fulfilled.

• Provide Subject Matter Expertise for audits

• Being up to date of international regulatory and compliance requirements related to the complaint system process.

• Other incidental duties

What You'll Need (Required):

• Bachelor's Degree in in related field, 8 years’ experience Required

• Master's Degree or equivalent in in related field Preferred

• 3 years’ experience in Quality Required

• Experience working in a medical device industry Required

What Else We Look For (Preferred):

• Proven successful project management leadership skills

• Proven expertise in Microsoft Office Suite and related tools and systems

• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Training and presentation skills required

• Extensive understanding of Quality Compliance procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline

• Extensive understanding of related aspects of Quality Compliance processes and/or systems

• Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of Quality Compliance to the business

• Strict attention to detail

• Ability to interact professionally with all organizational levels and proactiv