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Senior+
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Entry level
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OCMI, Inc. (O'Connor Construction Management)
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Irvine, California, United States · Hybrid
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The Senior Manager will lead a team of Supplier Quality Engineers to ensure performance, quality, and regulatory compliance across Contract Manufacturing Organizations. They are responsible for mitigating risks, managing quality agreements, and driving continuous improvement through data-driven strategies.
Requirements
Candidates must hold a Bachelor's degree in Engineering with at least 8 years of experience in Supplier Quality, Quality, or Manufacturing Engineering. Proven leadership in highly regulated industries, preferably medical devices or pharma, is required.
Full job description
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; or equivalent work experience based on Edwards criteria
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)
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.
Global leader in the medical device industry with a patient-focused culture of innovation
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1958
Headquarters
Irvine, CA
LinkedIn followers
432,416
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Contact Us
We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus
If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm.
All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
Medical DevicesHeart ValvesSurgical MonitoringStructural Heart DiseaseHealth Care TechnologyHeart InnovationsMedical InnovationsHeart Valve TechnologiesHeart Valve TherapiesTranscatheter Mitral &Tricuspid Therapies
Based on 1207 listings with disclosed salaries, most engineering jobs in Irvine, CA pay between $43k–$187k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Irvine, CA right now?
There are currently 1,412 open engineering positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Irvine, CA?
Companies currently hiring include Rivian, mouhamedzz, CoStar Group, Edwards Lifesciences, Young Community Developers, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Irvine, CA?
Yes — 403 of the 1412 open engineering positions offer remote or hybrid work (52 remote, 351 hybrid).
How do I apply for Engineering jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.