Edwards Lifesciences ยท 2 weeks ago
Quality Engineering Manager (2nd Shift)
Salt Lake City, UT
Full-time
Onsite
Mid, Senior LevelEdwards Lifesciences is a leading global structural heart innovation company dedicated to improving patient lives. The Quality Engineering Manager (2nd Shift) will manage a team focused on implementing and optimizing quality engineering practices while ensuring compliance with global regulatory requirements. This role involves collaborating with cross-functional teams and overseeing engineering tasks to enhance product development and patient outcomes.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Manage and/or lead a small team within assigned function. Develop team members to increase business acumen and functional skills
Work on complex issues where analysis of issues requires in-depth knowledge
Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables
Identify opportunities and lead the implementation of changes to drive improvements
Oversee engineering tasks; provide technical guidance and feedback to technicians/engineers; Guide lower level employees on more complex procedures
Create/update complex engineering documents including requirement specs, and risk documents with robust knowledge on design control requirements
Collaborate with cross-functional teams to lead the implementation of CAPA program including training, approvals, and system effectiveness
Other incidental duties
Qualification
Required
Bachelor's degree in engineering or related field, with experience in Quality Engineering, Quality Management, or Regulatory Compliance within the medical device industry; prior work in regulated industries preferred
Preferred
Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
Proven successful project management 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
Extensive understanding of engineering procedures while defining team operating standards
Extensive understanding of related aspects of quality engineering processes and/or systems
Extensive knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing
Basic financial acumen as it relates to quality engineering
Demonstrated skill set to manage small 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 influence cross-functional partners
Ability to integrate metrics into the projects and operations
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
Primarily interacts with internal subordinates and other supervisors
Typically interacts with external suppliers, vendors and/or customers
Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
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
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
2026-01-07
Orange County Business Journal
2026-01-04
BioWorld Financial Watch
2025-12-25
Company data provided by crunchbase