Overview
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. This Irvine‑based Senior Manager, Supplier Quality is responsible for overseeing a team along with supplier and receiving inspection activities for qualifying components in support of development, transfer, and launch of new aortic transcatheter valve replacement delivery system devices.
Responsibilities
- Provide oversight and mentorship for supplier quality engineers working with new product development and supplier development teams.
- Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessment.
- Act as project manager for all Supplier Quality tasks in support of the new product development process, reporting status at cross‑functional forums.
- Lead validation of suppliers, including supplier process validations and supplier reviews.
- Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
- Support manufacturing readiness reviews, supply chain readiness reviews, manufacturing transfers, and develop plans for the set‑up and transfer of components between facilities.
- Lead drawing reviews to ensure inspection DFX considerations are incorporated into designs and drive drawing changes where warranted.
- Implement new or updated quality agreements with suppliers, defining component specifications and control requirements (CTQs, control plans, SPC, ROC, etc.).
- Oversee supplier design and procurement of components, tooling, and fixtures for testing, inspection, or assembly.
- Ensure supplier files comply with qualification requirements.
- Lead continuous improvement initiatives, including quality system and procedure adjustments.
- Perform audits of approved suppliers’ quality management systems and provide subject‑matter expertise on cross‑functional technical assessments.
- Provide technical input for supplier selection, evaluation of capability, specification review, and part transition to manufacturing.
- Manage investigation and risk‑based escalation of non‑conformance issues.
- Manage staff development, ethics, and motivation through assignment of training activities.
- Ensure successful completion of all deliverables in accordance with project plans and timelines.
Qualifications (Required)
- Bachelor's degree with at least 8 years of experience in Supplier Quality, Manufacturing, New Product Development/Introduction, and/or Quality Engineering functions (or equivalent).
- Experience working within a highly regulated industry.
- Demonstrated people leadership experience and/or leading cross‑functional teams.
- Ability and willingness to travel 10–25% domestically and internationally (mostly domestic).
Preferred Qualifications
- Medical device industry experience.
- Experience with supplier/vendor management and qualification activities with new suppliers, CMOs, or OEMs.
- Experience with CAPAs, NCRs, change notifications, and/or auditing within a highly regulated environment.
- Demonstrated experience driving test method development and validation of test methods and equipment.
- Experience with CAD related to component and fixture design, inspection strategies, or test method development.
- Strong knowledge of DFM/DFX, component design reviews, and manufacturing capability assessment.
- Hands‑on experience with supplier validations (IQ/OQ/PQ, process validation, capability studies).
- Proven ability to evaluate supplier technical capabilities, including auditing, risk assessments, and capacity reviews.
- Experience supporting or leading new product introduction (NPI), design transfer activities, and manufacturing readiness evaluations.
- Proficiency in statistical analysis and use of quality tools (Six Sigma, DMAIC, DOE, SPC, Gage R&R, pFMEA, dFMEA, etc.).
- Demonstrated ability to troubleshoot complex quality issues and drive root cause & corrective action.
- Knowledge of manufacturing processes for molding, extrusions, machining, metals, textiles, or catheter sub‑assemblies.
- Knowledge of FDA and international regulatory standards (e.g., 21 CFR 820, ISO 13485 & ISO 14971) for medical devices.
- Demonstrated project management experience in a fast‑paced environment.
- Strong negotiation, influencing, and stakeholder management skills.
- ASQ CQE, CQA, Six Sigma Green Belt or Black Belt certification (preferred).
Pay Range
California: $139,000 – $196,000 (highly experienced). Pay depends on qualifications and experience.
Equal Opportunity
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement: All patient‑facing and in‑hospital positions require COVID‑19 vaccination unless a medical or religious accommodation is granted.
