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. 

Quality Engineer II, Chemistry

Responsibilities

• Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.

• Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.

• Improve key quality metrics (Fist Pass Acceptance, Quality Notifications and Complaint data).

• Develop department programs / processes on continuous improvement and standardization across the BD Diagnostic Systems.

• Supports the coordinated integration of new products into Manufacturing / Operations.

• Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.

• Develop Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements

• Understanding of Quality Systems and procedures

• Other emerging responsibilities as identified and assigned.

Job Summary:

The Quality Engineer is responsible for the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems. The Quality Engineer uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools. Works with various enterprise systems/Corporate directives to support new and/or current product lines and processes.

Typical assignments may include performing tasks, of moderate complexity, within planned schedules and timelines, test review for ROH release, water testing and OOS support, support for Validations of equipment and test methods, audits, actively participating on teams, ensuring documentation compliance, processing of CAPAs, change controls, and deviation waivers. Frequent interaction with other functional areas such as Research and Development, Operations, Facilities, etc.

May take the lead in root cause investigations for issues of moderate complexity.

Duties and Responsibilities:

• General:

  • The Quality Engineer (Chemistry) has responsibility for interpreting and applying the applicable Quality Systems and Regulatory Agency requirements. Ensures the documentation process remains compliant. Responsible for the day to day Quality Engineer responsibilities for assigned Quality Notifications, supporting and leading customer and supplier audits, active participation on functional and cross-functional teams, assigned project support, coordination and processing of CAPAs

  • Works under general direction, independently determines and develops approach to solutions

  • May provide guidance and work direction to lower-level project developers

• Cost Center Specific:

  • Provides advice, regarding implementation of Quality Systems to internal processes.

  • Coordinates, supports and monitors Quality Notifications, Deviation Wavers and Change Notifications.

  • Supports training to associates on GMP and other quality topics. 

  • Supports implementation of internal and supplier corrective/preventative actions and improvements by initiating and coordinating SAP data/documentation changes

  • Authors or reviews all internal document’s changes as well as quality procedures.

  • Performs metrics and drives for continuous improvement independently and within teams and recommends improvements, execute changes and verifies effectiveness of changes

  • Provides prompt response to inquiries from internal customers

  • Communicates information related to test procedures and process flow to internal customers. Participates in external projects as representative of QC Chemistry group.

  • Test review for Product results, raw material  release, water testing and OOS support

  • Documents audit nonconformities, coordinates and assures completion of CAPA, effectiveness verifications and continual improvement

  • Understands various chemistry testing processes

  • Supports internal projects and validations.

  • Prepares and maintains the QC Chemistry Validation Master Plan, including the Product & Process Table.

  • Ensures testing methods are validated according to regulatory requirements and the BD Validation Procedures.

  • Ensures equipment is PM / validated annually or as required.

  • Maintains MSA and Validation packages.

Knowledge / Skills:

• Must demonstrate a working understanding of the pertinent Quality Systems/Regulations (i.e.: Good Manufacturing Practices, ISO, FDA)

• Proven ability to develop solutions to a variety of problems of moderate scope and complexity.  Accesses policies and procedures for guidance

• Capable of using Microsoft programs and ability to learn other systems

• Working knowledge of statistical methods as well as statistical application software

• Strong verbal and written communication skills

• The ability to work in teams and independently with minimal supervision to obtain results as required

• Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects

• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.)

Education:

• BS or BA in Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs or other related field is required.   BS with 2 years relevant experience or MS with no experience required (project management experience preferred).

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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