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. 

Purpose of Position:

The Sr. / Staff Quality Engineer is responsible for supporting Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform.   The incumbent works multi-functionally with teams on change management projects (including those that may impact product design), design transfers, global expansion projects, risk management, process/product design and development, quality improvement projects (QIPs), and cost to win (CTW) projects.

General Functions, Specific Responsibilities, and Authority:

The Staff Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.), as well as R&D, Manufacturing, Sales, Marketing, Operations, Supply Chain, and Finance. The Sr. / Staff Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to product change regulatory submissions and regional expansions, with DCHU on complaint handling/resolution and field actions pre-/post - product launch, Packaging COE on new product packaging projects and changes, Sterility Assurance on sterilization process (re)validations and with Platform Management regarding product design and development, as well as design transfer activities.

Product Quality and Lifecycle Management:

• Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.

• Lead Quality Engineering Projects to improve Quality systems and Procedures.

• Support or lead activities related to managing changes, including conducting risk and design impact assessments.

• Update and maintain product Design History File (DHF) & Drug Master File (DMF) based on change activities.

• Coordinate mentorship with other Design Sub-team members. Develop design, process, and usability FMEAs. Maintain Risk Management File per ISO14971.

• Develop or assist in development and qualification of inspection and test methods and equipment. 

• Develop and document the Control Plan / System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.

• Support the development of manufacturing control plans for internal and outsourced processes.

• Support (or lead) development of the PFMEA, Process Requirements Specifications (PRS), and Validation Plans and Protocols including developing statistical sampling requirements.

• Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.

• Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, CMC, and ISO13485 requirements. 

• Lead supplier part qualification activities including mold qualification and DOEs (PPAP).

• Support Design / Process Transfers to the Production facilities as well as line expansion / capacity / productivity changes.

Other:

• Supports new global expansion efforts for existing products.

• Liaison between OUS quality and plant quality.

• Support the disposition investigation and decisions of rejected nonconforming components and products; conduct MRB action when required.

• Organize and generate detailed quality information reports to show trends and the impact of process improvements.

• Conduct other Quality Control Projects as assigned by the Manager of Quality Engineering.

• Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.

• Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.

• Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.

• Support goals of the Quality Assurance / Engineering Department.

• Mentor junior QE staff

Knowledge, Education, and Skills Required:

• Bachelor's degree in Engineering from an accredited four (4) year university.

• 5 - 8 years Quality Engineering experience with pharmaceutical, combination products, or medical devices.

• Pharmaceutical or combination product experience, preferred.

• ASQ Certified Quality Engineer (CQE), Six Sigma Black Belt (SSBB), or advanced degree or equivalent experience preferred.

• Experience operating in GLP, GMP, and GDP.

• Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred.

• Experience with ERP systems and software such as SAP, preferred.

• Attentiveness to details with strong organizational skills.

• Ability to work proactively and independently.

• Ability to multi-task and efficient in time management.

• Excellent verbal communication and interpersonal skills.

• Ability to work in a team environment.

• Proficiency in Excel, Word, and other desktop/general business systems.

• Approximately 15 - 20% travel may be required.

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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