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 any selected candidate 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 for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. 

The Senior Manager, Supplier Quality will provide direction and oversight of all of the production supplier quality activities, including interacting with receiving inspection, NCRs on supplier materials, managing supplier relationships, working with suppliers on corrective actions and changes to supplier processes, as well as incorporating new product introductions into the production supplier quality environment.  In addition, will oversee external manufacturing and material supplier quality for our Surgical BU and Implant Valve network, and provide supplier quality support to four manufacturing plants.

How you will make an impact:

• Plan and direct complex project activities with large scale or significant business impact with the accountability for successful completion of all project deliverables to the business. Develop project plans, schedule, scope, and quality objectives while using engineering methods, employing technical skills to recommend re-design/design on new supplier methods and/or processes.
• 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.
• Responsible for the oversite of the Supplier SCAR and NOC (Notice of Change) of programs including training, approvals, and system effectiveness.
• Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups
• Manage a team and oversee the work of one or more sub-function areas and 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 teams in the development of design recommendations that integrate into complex components or products
• Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options
• Other incidental duties as assigned

What you will need (Required Qualifications):

• Bachelor's Degree in a related field 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 Qualifications):

• Medical Device or Pharma industry experience
• Engineering degree
• Experience overseeing and managing Suppliers or CMOs, including managing audits, NCRs, SCARs, CAPAs, notification of changes with suppliers
• Manufacturing process controls knowledge and experience (process flow, FMEA, Control plans, Mistake Proofing, 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 $136,000 to $192,000 (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.