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. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
The Role
The primary purpose of this role is to lead a Quality Engineering team within the sustaining space and through transfers. The Quality Manager will report to the Quality Engineering Sr. Director onsite and will work collaboratively within a cross functional team to deliver products that meet customer expectations. Areas of responsibility may include but not limited to the following areas: Quality Engineering, Quality Operations, Quality Projects. Also collaborates in the process design and design transfer activities ensuring that adequate systems are properly validated and qualified to ensure to meet product requirements.
How Will You Make An Impact?
- Manage a team of Quality Engineers across Sustaining and projects.
- Provide coaching and mentoring through day-to-day activities associated with Quality Engineering.
- Represent Quality Engineering on the relevant tiered and core teams.
- Work cross functionally to deliver on project and sustaining deliverables.
- Lead NCR’s and CAPA’s activities associate with Quality.
- Lead and support in continuous improvement projects.
- Ensures that direct reports are appropriately trained for their respective job functions.
- Promote multifunctional team approach and Edwards cultural beliefs while ensure that expected project output meet the Quality requirements.
- Lead and support all activities associated with Audits.
- Resource projects and transfers related to area of responsibility.
- Other incidental duties.
What You Will Need?
- Bachelor's Degree in in Science or Engineering field.
- Medical device and cleanroom experience Required.
- Experience working in a regulated industry
What Else We Look For?
- 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
- Extensive understanding of Quality Engineering procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
- Proven 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 Engineering to the business
- Strict attention to detail
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
- Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
- 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
Skills Required
- Bachelor's degree in a science or engineering field
- Medical device experience
- Cleanroom experience
- Experience working in a regulated industry
- Proficiency with Microsoft Office Suite and related tools and systems
- Quality Engineering procedures and quality systems expertise
- Team management, coaching, and employee relations experience
- Problem-solving, organizational, analytical, critical thinking, communication, negotiation, and relationship management skills
- Ability to develop and integrate operational and project metrics
- Ability to work in a fast-paced, dynamic environment
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
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Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
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Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
