Job Description Summary

The Quality Engineer II is responsible for the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems. The Quality Engineer II uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools. Works with variable enterprise systems/Corporate directives to support new and/or current product lines and processes. Typical assignments may include, supporting one or more instrument platforms on sustaining items such as complaints, non-conformances and day to day issues, supporting audits, actively participating on teams, ensures documentation compliance, processing of CAPAs, change controls, and deviation waivers. Frequent interaction with other functional areas such as Research and Development, Operations, etc. is routine. The Quality Engineer II may take the lead in root cause investigations for issues of moderate complexity.

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. 

Responsibilities

• Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle.
• Develop Device History Files and maintain in a manner consistent with regulatory requirements.
• Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers.
• 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.
• Understanding and coaching others on Quality Systems and procedures.
• Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools.

Cost Center Specific:

• Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision.
• Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations.
• Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills.
• Knowledge of manufacturing processes, use of statistical tools required, and knowledge of microbiological and chemical test methods are preferred.
• Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred.

Education and Experience:

• BS in related field required with 2 years of quality and/or manufacturing experience
• Typically, a degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.

OR

• MS with 1 year of quality and/or manufacturing experience required (project management experience preferred)

Knowledge and 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
• Effective 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.)

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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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift