Sr. Supplier Quality Engineer

6206 Augusta Life Sciences US OpCo I LLC; Milpitas (CA); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Health & dental benefits

401(k) plan

Paid time off

Education assistance

Job summary

Waters seeks a Senior Supplier Quality Engineer to oversee supplier quality programs in a regulated manufacturing setting. You will drive supplier qualification, quality planning, risk analysis and collaboration across teams to ensure compliant, capable suppliers.

The role requires strong data analysis, communication skills, and experience with FDA/ISO requirements. On-site work in Milpitas with competitive compensation and benefits.

Qualifications

• Minimum 3 years of supplier quality experience in a manufacturing FDA or ISO regulated environment.
• Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs (CFR 820).
• ISO 9001/13485 lead auditing experience is a plus.
• Experience with SAP, Minitab and Quality Systems Software (e.g., TrackWise).

Responsibilities

• Provide guidance and quality oversight for key suppliers to meet Waters Quality, Regulatory and Industry standards.
• Ensure supplier controls meet FDA, regulatory requirements and support product improvements and customer needs.
• Lead supplier qualification and approval activities including quality planning, risk analysis, QT/QC reviews and supplier history files.

Skills

Supplier Quality

Six Sigma Green Belt

Project management

Regulatory compliance

Data analysis

Education

Bachelor’s degree in engineering or science

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.

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%

Employment Details

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.

Primary Work Location

USA CA - Milpitas 155

Additional Locations

CAN Québec - GeneOhm Sciences, USA GA - Grayson, USA NC - Mebane

Work Shift

At 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

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. At BD, we are the #MakersofPossible. Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

Equal Opportunity Employer

Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.