Supplier Quality Engineer

Job Description Summary

Job Description

We are the makers of possible

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.

Key Responsibilities:

* Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with BD Quality, Regulatory and Industry standard requirements. Ensure controls meet BD, 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 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 CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, Optics/Lasers, 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

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 Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need…