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.
The Supplier Quality Analyst will support new product development supplier quality in the approval, qualification and control of suppliers and purchased goods. This individual will facilitate compliance with 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 Regulatory Affairs.
How you will make an impact:
- Evaluate and analyze 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
- Compile data and generate reports for Supplier Quality Engineering and other internal customers
- 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
- Conduct monthly and quarterly Quality management metrics
- Develop and present training materials for quality system related processes
- Support projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires knowledge of organizational objectives.
- Other duties assigned by Management, including representing the department in corporate level initiatives.
What you'll need (Required):
- Bachelor's degree with at least one (1) year of experience working within a highly regulated industry; or equivalent work experience based on Edwards’ criteria.
- Must be willing to work on-site.
What else we look for (Preferred):
- Experience working within highly regulated environments: medical device, pharma, biotech, aerospace, automotive, or food industries.
- Experience with supplier quality, change controls, document controls, change management systems, and/or quality management systems.
- Skilled in creating dashboards and/or using Power BI, SQL, or similar tools.
- Advanced proficiency in Excel (pivot tables, formulas, statistical functions) to analyze large supplier-quality datasets.
- Experience with quality metrics and KPI reporting, including trend analysis and root‑cause identification.
- Demonstrated data analytics/interpretation capabilities.
- Good knowledge and familiarity with Good Manufacturing Practices (GMP).
- Proficiency in PowerPoint, with the ability to create and deliver clear, data‑driven presentations to cross‑functional teams.
- Good computer skills in MS Office Suite.
- Good written and verbal communication skills including negotiating and relationship management skills.
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 $55,000 to $78,000 (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.