Quality Engineering Manager

Edwards Lifesciences; Munster; On-site; EUR 90,000 - 130,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality Manager to lead a Quality Engineering team within sustaining and transfer projects. The role will report onsite to the Quality Engineering Sr.

Director and collaborate with cross-functional teams to ensure products meet customer requirements. The ideal candidate has a Bachelor's Degree in Science or Engineering, with medical device and cleanroom experience, and a proven track record in regulated environments.

Qualifications

• Bachelor's Degree in a Science or Engineering field.
• Medical device and cleanroom experience required.
• Experience working in a regulated industry.

Responsibilities

• 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 associated 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.

Skills

Team leadership

Quality engineering

Problem solving

Communication

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Tools

Microsoft Office

Job description

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 escal…
• 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