Job Description Summary

Job Description

We are the makers of possible 

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Summary:

The Sr Supplier Quality Engineer (SQE) is accountable for supporting Supplier Management activities through the application of Quality engineering skills for medical devices. The Sr SQE will 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, ISO, FDA, and other applicable regulatory requirements and identifying quality needs, product improvements, and customer requirements.  This role will support the OEM supplier management.

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

Functional Responsibilities:

• This role will provide support for BD Biosciences Reagents either at the San Diego site level or business unit level.

• Provides critical quality engineering direction to OEM Supplier Management with respect to accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.

• Establishes a strong working relationship with the OEM suppliers and internal BD customers to appropriately monitor and analyze raw material inspection, finished goods, and supplier process control activity.

• Serves as Quality liaison between BD and the OEM suppliers to identify, address, and resolve quality issues ensuring BD interests are met.

• Effectively addresses supplier quality issue by leading investigation at the suppliers, ensure the appropriate corrective action are implemented, and effective use critical Quality Engineering Principles.

• Authors technically sound supplier corrective action reports (SCAR), Quality Agreement with suppliers, supplier audit reports or supplier qualification reports.

• Strong technical writing is needed. Reports (i.e., SCAR report) must demonstrate strong analysis quantitative / qualitative analysis of data, summary of data, and conclusion or recommendations for corrective actions based on data.

• Takes a lead in identifying and documenting continuous improvement at BD suppliers.

• Authors or revises supplier related policies/procedures.

• Conducts supplier audits, (onsite or virtual) based on business needs.

• Leads or executes supplier qualification or requalification, which may include supplier audits or reviewing supplier documentations.

• Ensures supplier compliance and capability for qualification, approval, and sustaining activities.

• Provides quality support for Supplier Qualification are completed 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 need.

• Monitors critical suppliers for changes (for example supplier material change), and effectively assess the impact of the changes to BD product, conducts qualification due to the changes (if needed), and communicates the change to the business.

• Support investigation at the OEM supplier to address customer complaints and is capable of assessing products out in the field.  

• Strong technical writing of Situational Analysis documents. 

• Supports activities relating to Field Corrective Actions due to supplier quality issues, when needed.

• Develops solutions to routine problems of moderate scope.

• Follows company procedures and makes basic procedural updates.

• Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements.

• Develops and maintain supplier quality metrics and analyze the key quality parameters (such as Pareto analysis the root causes of supplier nonconformance) for leading indicator of potential quality issues.

• Effectively communicates and escalates supplier quality issues to the business to minimize impact to product availability and product quality.

• Maintains supplier quality scorecards with meaningful data that drive actions.

• Additional responsibilities evaluated and or added, based on business and quality needs.

• Performs other tasks assigned by management as required.

Education and Experience:

• B.S. in biological sciences or engineering degree.

• Requires at least 5 - 7 years of experience in Supplier Quality or Quality Engineering 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 preferred

• ASQ Certified Quality Engineer, ISO 13485 auditor or equivalent (preferred)

• Strong Biological science experience is preferred

Knowledge and Skills:

Knowledge

• Moderate knowledge of applicable regulatory requirements.

• Knowledgeable with ISO 9001, ISO 13485, ISO 14971.

• Breadth of knowledge in design control, risk management, supplier management.

Skills

• Statistical analysis. Class II / III medical device experience (preferred).   Ability to provide support to internal / external audits.

• Proficiency MS Excel, and MS Word required.

• Proficiency in written and verbal communication skills.

• Experience in SAP and Quality Systems Software (e.g., Track wise) is preferred

Physical Demands: (if applicable)

• Role is 70% use of laptop or desktop computer, hence sitting or standing.

• Remaining 30% standing or walking.

• There may be 10% traveling to support supplier audit.

Work Environment: (if applicable)

• 100% onsite model.

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 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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. 

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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information