Senior Manager, Supplier Quality - Contract Manufacturing (CMO)

Edwards Lifesciences • Irvine, CA • 2h ago

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

We are seeking a strategic and collaborative Senior Manager, Supplier Quality to lead and evolve our Supplier Quality program supporting Contract Manufacturing Organizations (CMOs). This role will play a critical leadership function within Edwards Supplier Management organization ensuring supplier performance, product quality, and regulatory compliance across a portfolio of finished medical devices distributed directly to market. The successful candidate will lead a high-performing team of Supplier Quality Engineers while partnering closely with internal stakeholders across Supplier Development, Sourcing, and Business Unit Lifecycle Management teams to strengthen supplier relationships, proactively mitigate risk, and scale quality systems to support both new product introductions and early commercialization. This is a highly visible, high-touch role requiring strong technical expertise, leadership capability, and the ability to influence both internal teams and external suppliers.

How you will make an impact:

Manage supplier management project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives utilizing lean manufacturing and error proofing. 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 a supplier quality 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

Identify risk, develop and lead in the implementation of supplier quality strategies which may include negotiations with internal and external parties

Lead the implementation of quality agreements with suppliers that include requirements for component specifications that details control requirements such as component's CTQs (Critical to Quality), control plans, SPC (statistical Process Controls) and other continual improvement tools

Perform complex quality trend analysis from supplier base and facilitate corrective actions as appropriate and effectively address root causes of quality issues.

Assess supplier performance against contractual obligations, scorecards and key performance indicators

Other incidental duties

What you will need (Required):

Bachelor's Degree in Engineering with at least 8 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering

Highly regulated industry experience

Demonstrated people leadership and/or leading cross-functional teams

What else we look for (Preferred):

Medical Device or Pharma industry experience

Experience overseeing and managing Suppliers or CMOs, including managing audits, NCRs, SCARs, CAPAs, complaint investigations, post-market quality monitoring and notification of changes with suppliers

Experience supporting Contract Manufacturing Organizations (CMOs) producing finished medical devices, including accountability for end-to-end product quality and performance

Experience with electronics, PCBA, or electro-mechanical assemblies

Manufacturing process controls knowledge and experience (process flow, Lean Manufacturing, FMEA, Control plans, Statistical Process Control,).

In-depth knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)

Proven successful project management leadership skills

Project Management Certification or experience.

Knowledge of DMAIC Six Sigma concepts

In-depth knowledge of Quality Management Systems and Processes

Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering

ASQ certification / Certified Lead Auditor

Proven expertise in both Microsoft Office Suite and related systems

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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