Senior Manager, Quality

Edwards Lifesciences

9d

About The Position

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Manager, Quality position is a unique career opportunity that could be your next step towards an exciting future. Manage the receiving inspection team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in incoming goods. Oversee process audits and part release documentation. Advise and facilitate failure investigations, compliance methodologies incoming materials. How You'll Make an Impact: Manage supervisors and/or oversee the work of assigned receiving inspection team within own function, one or more production line or projects. Develop a robust talent development plan in alignment with functional growth strategies of the department. Manage quality assurance project activities (e.g., CAPA) 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 Collaborate with cross-functional groups to manage inspection incoming goods and components including proper implementation Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement Identify opportunities and lead the implementation of changes to drive improvements Other incidental duties

Requirements

• Bachelor's Degree in related field and skill levels exceeding the requirements of the Superintendent or equivalent work experience based on Edward's criteria.
• Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices or equivalent work experience based on Edwards criteria
• Demonstrated track record in people management or equivalent work experience based on Edwards criteria

Nice To Haves

• Experience working in a regulated industry or equivalent work experience based on Edwards criteria
• Preferred Proven successful project management leadership skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and related quality systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• 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
• Expert knowledge of applicable quality regulations (e.g., cGMP compliance)
• 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
• 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 subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers 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

Responsibilities

• Manage supervisors and/or oversee the work of assigned receiving inspection team within own function, one or more production line or projects.
• Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Manage quality assurance project activities (e.g., CAPA) 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
• Collaborate with cross-functional groups to manage inspection incoming goods and components including proper implementation
• Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement
• Identify opportunities and lead the implementation of changes to drive improvements
• Other incidental duties

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees