Job description

Position Overview:
The Supplier Quality Analyst will support TMTT Supplier Quality - New Product Development in the approval, qualification and control of suppliers and purchased goods. 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 Quality, R&D, Operations, Sourcing, and RA.

Key Responsibilities:

• Evaluate and analyze moderately complex technical information and data related to quality indicators and recommend course corrections. Draft presentations and present summaries of trends, potential root causes, and recommended course corrections
• Draft updates to Quality procedures and conduct reviews to finalize procedures
• Coordinate document, drawing and receiving router changes
• Develop technical justifications and other content for Engineering Change Request (ECR) submissions
• Maintain and update the Approved Supplier List (ASL), including: Initiating SARs, coordinating with engineers, managing project priorities, and reviewing content for accuracy
• Conducting monthly and quarterly Quality management metrics
• Compile data and generate reports for Supplier Quality Engineering and other internal customers
• Identify root cause and suggest corrective actions in initial non-conformance investigations
• Develop and present training materials for quality system related processes
• Lead small scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires knowledge of organizational objectives. Drive to resolve these issues completely and with speed by leveraging your network of key contacts within and outside your own area of expertise.
• Other duties assigned by Management, including representing the department in corporate level initiatives.

Required Qualifications:

• Bachelor's Degree or equivalent in related field
• Three (3) years of experience in supplier quality, change controls, document controls, change management systems, and/or quality management systems
• Experience working within a regulated environment

Preferred Qualifications:

• Experience working in these specific regulated environments: medical device, pharma, biotech, aerospace, automotive, or food industries
• Good knowledge and familiarity with Good Manufacturing Practices (GMP)
• Good computer skills in MS Office Suite
• Previous experience in change control or document control preferred
• Experience with change management systems preferred
• Good written and verbal communication skills including negotiating and relationship management skills
• Fundamental project management skills a plus
• Full knowledge of Good Documentation Practices (GDP)

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 $69,000 to $97,000 (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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