Supplier Quality Engineer II (Transcatheter Heart Valves)
Company: Edwards Lifesciences Gruppe
Posted on: February 18, 2021
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Role Description: The Supplier Quality Engineer II will directly
support the design and development teams in qualifying critical
materials and suppliers in support of launching innovative &
life-saving medical devices. This individual will facilitate
compliance to applicable internal and external requirements. You
will work in a fast-paced and dynamic environment where taking
initiative and collaborating cross-functionally are critical for
success. This role will work in close partnership with R&D,
Operations, Quality, Sourcing, and Regulatory Affairs.
- Responsible for ensuring compliance with all Federal, State,
local, and company regulations, policies, and procedures.
- Works with suppliers to ensure quality system and supplied
product requirements are understood and successfully met.--
- Responsible for helping define supplier qualification
requirements for OEM and custom materials and devices.
- Ensures validation methods of critical suppliers and incoming
quality control are aligned with device risk, internal
requirements, international standards, global regulations, and
Industry best practices.
- Supports completion of Design History File requirements
applicable to supplied components, subassemblies, devices, and
- Supports risk management activities with suppliers.
- Executes test method validation activities for receiving
inspection and/or supplier final release.
- Knowledge of CAPA elements is preferred.
- Assesses non-conformances and leads closure of SCARs as
-- Required Education / Qualifications:
- Bachelor's degree in Engineering or Scientific field with at
least 2 years of experience with supplier quality, manufacturing,
or quality engineering functions
- Highly regulated industry experience Preferred Qualifications:
- Experience with supplier quality engineering activities,
including external supplier vendor audits
- Effective problem-solving techniques and experience with
technical tools (i.e. Root Cause Analysis, dFMEA process, Gage
- Proficient understanding of Design Controls, test method
development & validation, and risk management.
- Conduct effective root cause investigations; assessment of
corrective action strategies; and effectiveness as applied to NCRs
- Experience with class II and class III medical devices
- Medical device, pharma, biotech or other regulated industry
- Demonstrated ability to apply statistical quality engineering
- Ability to read and interpret drawings
- Knowledge and understanding of FDA and international regulatory
standards for medical devices is preferred.
- Ability to manage multiple and frequently changing projects and
- Ability to work independently without close supervision
- Effective communication and conflict resolution skills
- Highly developed time management, communication, and
- Strong communication and organizational skills to effectively
manage and get results with external suppliers
- Six Sigma Black Belt/LEAN Manufacturing experience
- ASQ Certified Quality Engineer or ASQ/BSI Certified Quality
- Domestic and international travel up to 25% (post-COVID)-- E
dwards is an Equal Opportunity/Affirmative Action employer
including protected Veterans and individuals with disabilities.
Posted 3 Days Ago Full time Req-6240 About Us Edwards Lifesciences
is the global leader in patient-focused medical innovations for
structural heart disease, as well as critical care and surgical
monitoring. Driven by a passion to help patients, the company
collaborates with the world's leading clinicians and researchers to
address unmet healthcare needs, working to improve patient outcomes
and enhance lives. Headquartered in Irvine, California, Edwards
Lifesciences has extensive operations in North America, Europe,
Japan, Latin America and Asia and currently employs over 15,000
individuals worldwide.-- For us, helping patients is not a slogan -
it's our life's work. From developing devices that replace or
repair a diseased heart valve to creating new technologies that
monitor vital signs in the critical care setting, we focus on
helping patients regain and improve the quality of their life.
Keywords: Edwards Lifesciences Gruppe, Irvine , Supplier Quality Engineer II (Transcatheter Heart Valves), Engineering , Irvine, California
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