Edwards Lifesciences ยท 17 hours ago
Senior Manager, Quality Engineering (Metals)
Draper, 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 Engineering position involves managing Quality Engineers to ensure medical device quality compliance and product safety in Metals Operations.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Oversee the Quality Engineers (QEs) responsible for supporting daily production activities. Focus on reducing line downtime by actively managing site Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Engineering Change Requests (ECRs) related to both production and process validation
Define and lead the development of Tier Metric indicators across all levels of the organization
Conduct Metals Quality Reviews and provide inputs for Site Quality Data Reviews
Identify and implement preventative actions based on ongoing monitoring of production metrics
Partner with Manufacturing Engineering (ME) and Operations teams to review real-time process monitoring data
Initiate improvement projects based on analysis of process inputs and outputs
Prioritize improvement initiatives using risk-based approaches such as A3, Six Sigma Black Belt methodologies, and related tools
Assess the capabilities of inspection and control methods, implementing improvements to lower control risk levels
Perform Test Method Validations (TMVs) as needed to ensure ongoing process reliability
Manage process Failure Mode and Effects Analyses (pFMEAs) to facilitate accurate risk assessments for CAPAs, NCRs, and customer complaints
Lead the development and execution of CAPA and NCR strategies, and provide mentorship and coaching to engineers involved in these activities
Lead investigations into Product Risk Assessments (PRAs) and complaints related to manufacturing issues
Support product release activities, including process validation, to ensure compliance and product quality
Understand Metals Chemistry and support process characterization and validation activities aimed at improving process capability
Participate in internal line and process audits, as well as external audit roles, providing technical expertise and support
Manage material quality control, including PRA, Complaint investigations, containment and stop-ship decisions
Assess and make disposition decisions for products on hold, such as those marked with Material Review Board (MRB) or yellow tags
Provide technical support during both internal and external audits
Oversee process and equipment software validation and governance to ensure compliance with regulatory requirements
Support the qualification and requalification of sterilization cycles, focusing on product impact rather than microbial aspects
Contribute to the validation of critical systems, especially for point-of-entry corrective maintenance activities
Coach and mentor team members, fostering talent development and succession planning
Encourage accountability and continuous learning, while striving to attract top talent in advanced quality manufacturing
Qualification
Required
Bachelor's Degree in related field, related experience in engineering or equivalent work experience based on Edwards criteria
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent work experience based on Edwards criteria
Demonstrated track record in management of technical and/or engineering disciplines or equivalent work experience based on Edwards criteria
Preferred
Experience working in a regulated industry or equivalent work experience based on Edwards criteria
Certified Quality Engineer
Six Sigma Black Belt/Lean Black Belt
Proven project management, leadership and medical device audit leader skills
Proven expertise in both Microsoft Office Suite and related 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
Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
Expert understanding of related aspects of quality engineering processes and/or systems
Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
Expert knowledge and coaching experience for design of experiments, process capability studies, failure mode and effects analysis, statistical process monitoring/control, test method design for manufacturing and Lean Manufacturing
Knowledge of financial acumen as it relates to the business as well as quality engineering
Demonstrated ability to direct teams 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
Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
Demonstrated audit experience, technical writing experience and assuring documentation compliance
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
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
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
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
2026-01-07
Orange County Business Journal
2026-01-04
BioWorld Financial Watch
2025-12-25
Company data provided by crunchbase