Senior Manager, Quality (Laboratory) presso Edwards

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

We recently announced plans to expand in Spain by building a new, state-of-the-art manufacturing plant in Moncada, Valencia. When it becomes operational in 2026, the plant will manufacture Edwards' surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 dedicated team members by 2029 across manufacturing, engineering, and several other professional career paths. Hiring for professional positions has started and will continue through the winter and early spring, with specialized training for manufacturing hires beginning in the fall of 2025.

How you will make an Impact:

• Manage team to ensure smooth and continuous operations in quality.

• Manage quality area including execution of activities towards quality improvements and strategies with ability to resolve and prevent diverse issues

• Manage supervisors, professionals/engineers, and/or oversee the work of assigned quality team within own area and/or projects. Drive quality culture, engage staff morale, and ensure employees' safety.

• Develop a robust talent development plan in alignment with functional growth strategies of the assigned area(s)

• Responsible for achieving and/or exceeding quality objectives

• Manage quality project activities with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups

• Negotiate solutions with cross-functional groups (e.g., Manufacturing, Supply Chain, and Engineering) for continuous improvement

• Identify opportunities and lead the implementation of changes to drive improvements

• Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. Define effective and efficient business process workflow, including process modifications in partnership with stakeholders

• Other incidental duties

What you will need (Required):

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

• Demonstrated track record in people management

• Demonstrated technical expertise within assigned quality area

• Experience working in a regulated industry

What else we look for (Preferred):

• Proven successful project management leadership skills

• Proven expertise in Microsoft Office Suite; experience in related quality systems

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

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

• Understanding of Six Sigma/Lean Black Belt

• Expert understanding of quality procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

• Expert understanding of related aspects of quality processes and/or systems

• Expert knowledge of financial acumen as it relates to quality including forecasting

• Demonstrated ability 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 to the business

• Extensive knowledge of Process Validation and Risk Management (only Eng, Ops)

• Knowledge and adherence to applicable regulatory requirements (e.g., ISO 13485, QSR)

• 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

• Knowledge of Lean Manufacturing concepts and Six Sigma

• Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team

• Participate and present at meetings with internal and external representatives

• Resolve operational and scheduling issues

• Dedicated to quality client service and pro-active and responsive to client needs.

• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

• Develop relationships and leverage them to influence change

• Support and solicit input from team members at all levels within the organization

• 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