Job description

Job Description:
The Senior Supplier Quality Engineer is a key role of an innovative and challenging project within Transcatheter Mitral and Tricuspid Therapies (TMTT). This is a cross-functional position in partnership with the Quality, R&D, and Operations with a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Quality Engineer will work on-site in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

Responsibilities:

• Plan, direct, and approve supplier validations, capability analyses and gage studies based on risks identified in FMEAs
• Manage supplier related non-conformances
• Manage supplier corrective actions from initiation to closure
• Manage component and supplier qualification activities using tools such as PQTM's, statistical analysis, quality agreements etc.
• Oversee and develop supplier metrics such as PARETO charts and/or control charts.
• Continually assess the Supplier Management and QA Management system and SOP’s for continual improvement
• Drive Deliverables to obtain Supplier Approval.
• Conduct onsite supplier audits

Required Qualifications :

• Bachelor’s degree in engineering or scientific field and 4 years related experience, or Master’s degree in engineering or scientific field and 3 years related experience
• Ability to travel up to 25%

Preferred Qualifications:

• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor or Six Sigma Black Belt certified preferred
• Audit training, ability to develop an audit plan, execute, and write effective audit findings
• Previous medical device or pharmaceutical industry experience

Additional Skills:

• Ability to conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
• Strong geometric dimensioning and tolerancing (GD&T) knowledge for print specifications
• Thorough understanding of Root Cause Analysis principles, FMEA process and development, GR&R and process capability
• Thorough understanding of Process Validation (IQ, OQ, PQ)
• Ability to develop statistically appropriate inspection plans at suppliers that incorporate critical to quality features and risk analysis
• Strong understanding of manufacturing processes like injection molding, extrusion, machining, etc.
• Thorough understanding of risk management principles
• Strong communication and organizational skills to effectively manage and get results with external suppliers

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, the base pay range for this position is $101,000 to $142,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

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 13,000 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.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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Family and Medical Leave Act (FMLA)
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