Senior Manager, Supplier Quality

Edwards Lifesciences; California (MO); Hybrid; USD 136,000 - 192,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Supplier Quality to lead and optimize quality activities across production suppliers. This role involves overseeing supplier relationships, ensuring compliance with quality standards, and managing cross-functional teams to drive project success. With a focus on innovative solutions and a commitment to excellence, you'll play a pivotal role in shaping the future of healthcare technologies. Join a team where your expertise will directly impact patient care and contribute to groundbreaking advancements in the medical device industry.

Benefits

Competitive salaries

Performance incentives

Comprehensive benefits

Qualifications

• 8+ years of experience in Supplier Quality Engineering or related fields.
• Experience in highly regulated industries is essential.

Responsibilities

• Plan and direct complex project activities with significant business impact.
• Lead the implementation of quality agreements with suppliers.

Skills

Supplier Quality Engineering

Quality Management

Project Management

Leadership

Quality Assurance

Education

Bachelor's Degree in a related field

Tools

Microsoft Office

Job description

This role is technically based in Irvine, CA, but with flexibility for a “hybrid work designation”. Candidates residing in Southern California are expected to work onsite at our main Irvine campus 2-3 days per week. For candidates living out of state or in Northern California, travel to Irvine will be required once or twice a month.

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 throughout a product’s lifecycle. Your work will involve optimizing product development to impact patients around the world with pioneering technology.

Senior Manager, Supplier Quality

This role provides direction and oversight of all production supplier quality activities, including interaction with receiving inspection, NCRs on supplier materials, managing supplier relationships, working with suppliers on corrective actions and process changes, and integrating new product introductions into the production supplier quality environment. The role also oversees external manufacturing and material supplier quality for our Surgical BU and Implant Valve network, providing supplier quality support to four manufacturing plants.

How you will make an impact:

1. Plan and direct complex project activities with significant business impact, ensuring successful completion of all project deliverables. Develop project plans, schedules, scope, and quality objectives, using engineering methods and technical skills to recommend redesigns or new supplier processes.
2. Lead the implementation of quality agreements with suppliers, detailing control requirements such as component CTQs, control plans, SPC, and other continual improvement tools.
3. Oversee the Supplier SCAR and NOC programs, including training, approvals, and system effectiveness.
4. Identify risks, develop mitigation strategies, and resolve issues collaboratively with cross-functional teams.
5. Manage a team and oversee work in one or more sub-function areas, with some budget responsibilities.
6. Develop a talent development plan aligned with the department’s growth strategies.
7. Provide technical guidance to cross-functional teams on design recommendations for complex components or products.
8. Lead efforts to optimize business processes and systems through assessment and technology solutions.
9. Perform other duties as assigned.

Required Qualifications:

• Bachelor's Degree in a related field with at least 8 years of experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering.
• Experience in highly regulated industries.
• Proven leadership in managing cross-functional teams and people.

Preferred Qualifications:

• Experience in Medical Device or Pharma industries.
• Engineering degree.
• Experience managing suppliers or CMOs, including audits, NCRs, SCARs, CAPAs, and change notifications.
• Knowledge of manufacturing process controls, FMEA, control plans, mistake-proofing, SPC.
• Understanding of domestic and international regulatory standards (FDA, GMPs, ISO/EN).
• Successful project management leadership and PMP or similar certification.
• Knowledge of DMAIC Six Sigma concepts.
• Deep understanding of Quality Management Systems and Principles of Quality Engineering.
• ASQ certification or Certified Lead Auditor.
• Proficiency in Microsoft Office and related systems.

We offer competitive salaries, performance incentives, and comprehensive benefits to support our employees and their families. The base pay range in California is $136,000 to $192,000, depending on qualifications and experience. Applications are accepted while the position is posted on our Careers website.