Edwards Lifesciences Corp

Senior Manager, Quality Engineering & Quality Assurance

Edwards Lifesciences Corp • $110K — $130K *
Salt Lake City, UT 84118In-Person
Manufacturing & Automotive
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering related to Materials, Chemical, Mechanical, or Metals.
  • Experience in Quality Engineering or Quality Management within the medical device industry.
  • Proven management record in technical and engineering disciplines in a Quality/Manufacturing Environment.
  • Strong knowledge of medical device quality system and regulatory requirements, including FDA and ISO 13485.

Responsibilities

  • Serve as the quality representative for Metals during internal and external audits, ensuring alignment with site quality objectives.
  • Manage and develop the quality assurance team, driving a robust talent development plan.
  • Oversee quality assurance project activities (e.g., CAPA), ensuring timely and complete delivery of quality objectives.
  • Collaborate with cross-functional groups to manage inspections of in-process and finished goods.
  • Negotiate continuous improvement solutions with cross-functional teams such as Manufacturing and Engineering.
  • Utilize engineering methods (e.g., Six Sigma, Lean) to manage projects, ensuring quality outcomes within time and budget constraints.
  • Provide technical guidance for design recommendations in the development of components and products.

Benefits

  • Collaborative work environment with cross-functional teams.
  • Opportunities for professional development and career growth.
  • Engagement with innovative manufacturing processes in the medical devices field.
  • Involvement in ensuring high quality and compliance in product output.
Full Job Description
The Senior Manager, Quality Engineering & Quality Assurance will manage the Metal Manufacturing team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of Metal Components. Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.

How You'll Make an Impact:

  • Quality representative for Metals associated with internal and external audits. Coordinate with Draper Quality Systems Management for audit preparation, execution and action plans. Ensure Metals Organization executes to Draper site quality objectives/plans
  • Manage supervisors and/or oversee the work of assigned quality assurance 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. Identify opportunities and lead the implementation of changes to drive improvements
  • 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 including training, approvals, and system effectiveness. 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 of in-process and finished goods, assemblies and components including proper implementation
  • Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement
  • Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
  • Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department
  • Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity. Collaborate with Campus Model shared services to support Draper Metals Organization.


What You'll Need (Required):

  • Bachelor's degree in related field related experience in Materials, Chemical, Mechanical and/or Metals engineering.
  • Experience in Quality Engineering or Quality Management within the medical device industry with demonstrated Product Quality decision-making, or equivalent work experience based on Edwards' criteria.
  • Demonstrated track record in management of technical and/or engineering disciplines in a dynamic Quality/Manufacturing Environment.


What Else We Look For (Preferred):

  • Technical quality leadership experience supporting metals manufacturing, metal components, or precision-manufactured components.
  • Experience supporting commercial production quality for processes such as machining, forming, chemical processing, laser cutting, tubing, nitinol, or other metal component manufacturing processes.
  • Demonstrated experience leading both Quality Engineering and Quality Assurance functions, including oversight of NCRs, CAPAs, TMVs, inspection readiness, product release, and quality metrics.
  • Experience managing Supervisors and associated direct and indirect manufacturing inspection and/or testing resources.
  • Experience managing or partnering closely with inspection, quality control, and manufacturing operations teams to ensure in-process and finished goods meet quality, compliance, and release requirements.
  • Medical Device external audit leadership experience
  • Proven ability to serve as a quality representative during internal, notified body, FDA, customer, or external regulatory audits, including audit preparation, execution, response, and action plan management.
  • Strong working knowledge of applicable medical device quality system and regulatory requirements, including FDA Quality System Regulation, ISO 13485, GMP, and global quality standards.
  • Experience using quality engineering tools and statistical methods such as process capability, statistical process control, FMEA, DOE, test method validation, root cause analysis, Lean, and Six Sigma.
  • Demonstrated ability to lead technical quality investigations, drive risk-based decision-making, and implement sustainable corrective and preventive actions in a high-volume or complex manufacturing environment.
  • Experience developing and using quality metrics, management review inputs, and operational dashboards to monitor trends, communicate risks, and drive continuous improvement.
  • Certified Quality Engineer, Six Sigma Black Belt, Lean certification, or equivalent quality/manufacturing certification.

About Edwards Lifesciences Corp

Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland.
Learn more about Edwards Lifesciences Corp
Size
15,700 employees
Market Cap
$45.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$823.4 million
Founded
1958
5 Year Trend
+12%
Revenue
$4.3 billion
NASDAQ
EW
* Ladders Estimates

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