Sr. Supplier Quality Engineer

Becton Dickinson; Milpitas (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Waters is seeking a Supplier Quality professional to oversee supplier qualification, quality planning, and risk management in a regulated environment. You will collaborate with suppliers to ensure design controls and GMP compliance throughout the product lifecycle.

The role requires strong leadership, data analysis skills, and experience with SAP/Minitab/TrackWise. Travel up to 20% may be required as part of supplier audits and assessments.

Qualifications

• Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs CFR 820.
• Excellent people interaction, team building, leadership, and communication skills; including effective presentations.
• Strong background in manufacturing processes including process development and optimization.
• Experience managing a variety of commodities including Instrument Finished Goods, Optics/Lasers, CMs, PCBAs/Electronics, Sheet metal, Machined Parts, Cabling harnesses or Chemistry/Biological products.
• Proficient in project management, analytical, critical thinking, problem solving, and prioritization skills.
• Demonstrate knowledge of statistics and data analysis to drive data-based decisions.
• ISO 9001/13485 lead auditing experience.
• Experience with SAP, Minitab, TrackWise and Quality Systems Software is a plus.

Responsibilities

• Provide guidance and quality oversight for key suppliers to ensure alignment with Waters Quality and regulatory requirements.
• Drive and support new product development and sustaining activities in supplier management; ensure qualification, approval, and sustaining records.
• Support supplier qualification/approval steps across supplier selection, quality planning, risk analysis, QMS reviews, and related documents.
• Support Field Corrective Actions when needed.
• Facilitate and partner with suppliers to develop strong business and quality relationships.
• Establish initiatives to improve Supplier Quality Management Systems.
• Lead Supplier Capability Assessments.
• Willingness to travel up to 20%.

Skills

Leadership

Communication

Project management

Analytical

Problem solving

Data analysis

Statistics

Education

B.S./B.A. in engineering or science

Six Sigma Green Belt

ASQ Certified Quality Engineer

Six Sigma Black Belt (preferred)

Tools

SAP

Minitab

TrackWise

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Key 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.
• Lead Supplier Capability Assessments
• Ability to travel 20%

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

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.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Ac