Edwards Lifesciences · 8 hours ago
Senior Manager, Quality
Salt Lake City, UT
Full-time
Onsite
Senior LevelEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Senior Manager, Quality position involves managing the receiving inspection team and overseeing quality control and assurance inspections for incoming goods, while also leading quality assurance project activities and collaborating with cross-functional teams to drive improvements.
BiotechnologyHealth CareMedicalMedical Device
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
Qualification
Required
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
Preferred
Experience working in a regulated industry or equivalent work experience based on Edwards criteria
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
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
Founded in 1958
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase