Overview
The Sr. Supplier Quality Engineer, who works under the direction and supervision of the Director of Global Supplier Quality, works in a cross-functional team environment and will drive our quality program efforts. This position will work independently and resolve Supplier Quality related issues in a timely manner and drive customer satisfaction.
This position is hands-on in a fast-paced environment which will interact with external suppliers and multiple internal functions (R&R, Engineering, Test Engineering, Reliability, Regulatory, Purchasing, sister manufacturing sites and contract manufacturers) to resolve supplier quality issues such as electrical schematics, PCBs, PCBAs, software, circuit design.
Responsibilities
- Drive and Support New Product Development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities.
- Execute Supplier Qualification and Approval steps and ensure that they are completed adequately including areas in supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and DFM reviews, validations, verifications, quality agreements, supplier history files and other activities as needed.
- Support supplier investigations to ensure root causes are determined and appropriate corrective actions are implemented to prevent repeat non-conformances
- Lead effective Supplier Corrective Action and Preventative Action (CAPA) investigations
- Determine adequacy of part acceptance activities and make necessary improvements
- Communicates effectively within the project teams as well as Sr. Leadership through project reviews and status reports including preparing reports and supplier KPI metrics
- Facilitate and Partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration
- Conduct supplier audits to determine effectiveness of QMS and Process Control (both qualification and ongoing maintenance audits)
- Assist in the qualification and disqualification of suppliers, initiate improvement plans when necessary
- Develop and implement Quality Plans with critical suppliers
- Monitor supplier processes and performance
- Drive continuous improvements of the quality program
Qualifications
Education:
- Qualified individual should have a Bachelors Degree in Engineering (Electrical, Chemical, Software), Science, or related technical field.
Experience:
- Minimum of 6 years work experience in Quality Assurance or related field.
- Experience within a regulated industry (21 CFR 820, 21 CFR 211, ISO13485, AS9100, TS16949) is preferred.
- Minimum 3 years of experience in Supplier Quality or related field.
- Leadership, facilitation and communication skills
- Knowledge of quality tools such as PPAP, statistics, SPC, PFMEAs, Control Plans, 8D, Change Management, Process Control Audits
- Ability to work independently across multiple organizations
- Good report writing and reviewing skills
- Working knowledge of electrical schematics, PCBs, PCBAs, software, circuit design
- Ability to travel up to 30% domestic and international
Desired Qualifications:
- Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing-GD&T), and/or electrical and fluidic schematics.
- ASQ certification(s)
- Operational Excellence/Six Sigma/Lean training or certifications.
- Experience using SAP or Oracle and Sparta Trackwise helpful.
- Knowledge of various quality systems
Company Description
Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.