Job DescriptionKey Responsibilities:- Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with Waters Quality, Regulatory and Industry standard requirements. Ensure controls meet WATERS, FDA, and other applicable regulatory requirements and identifying quality needs, product improvements and customer requirements
- Drive and Support new product development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities. Ensures adequate design control documentation and records are maintained to support life cycle of design history
- Provide quality support for 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 activities relating to Field Corrective Actions, when needed
- Facilitate and Partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration
- Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems.
Education and Experience:- B.S. or B.A. degree in an engineering or science field.
- Minimum of 3 years of experience in Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment
- Six Sigma Green Belt and/or Certified (e.g. ASQ) Quality Engineer or equivalent (Prefer Six Sigma Black Belt Certified) desired
Minimum Qualifications:- Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820
- Excellent people interaction, team building, leadership, and communication skills including providing effective presentations.
- Strong background in Manufacturing processes including process development and optimization
- Experience in managing variety of commodities including Instrument Finished Goods, Optics/Lasers, CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, and Cabling harnesses or Chemistry or Biological products
- Proficient in project management, analytical, critical thinking, problem solving and prioritization skills
- Demonstrate innovative and implementation skills
- Demonstrate knowledge of Statistics and Data Analysis to drive data-based results and decisions
- ISO 9001/13485 lead auditing experience
- Strong solving skills at both process and product level
- Experience in SAP, Minitab, and Quality Systems Software (e.g. TrackWise) is a plus
- Lead Supplier Capability Assessments
- Ability to travel 20%
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Primary Work LocationUSA CA - Milpitas 155
Additional LocationsCAN Québec - GeneOhm Sciences, USA GA - Grayson, USA NC - Mebane
Work ShiftAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
Benefits may include:Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.
Additional details regarding benefits and well-being programs can be found in Our Commitment to You.
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information$110,200.00 - $176,400.00 USD Annual
