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. 

Responsibilities

• Represent the Corporation, Business Unit and Quality Department in a professional manner.

• Handle and ensure proper implementation of all Quality Engineering duties and responsibilities. Hire, train, develop, review, and lead exempt and/or non-exempt employees as assigned.

• Provide Quality Engineering leadership for New Product Development (NPD), Sustaining Engineering (SE) and transfer to manufacturing.

• Provide Quality Engineering technical support to assist in resolving quality issues, including but not limited to, complaint review and investigation.

• Prepare and implement Business Unit policies relating to quality, project management, product/process development, and design control regulations, etc.

• Participate on project teams as the Quality Representative.  Ensure that principals of Design Control are applied to Product and Process Changes and New Product Development.

• Provide technical support for Home Care Platform Project Teams and the Quality Department.

• Create, review and approve Quality System Documents, including Product Documents for products purchased, manufactured and/or distributed by BD UCC.

• Create, review and approve Protocols, Process and Product Validations, Stability Protocols etc. to support the Design History File (DHF)

• Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA).

• Lead efforts to identify, investigate, and create plans to respond to potential product issues involving distributed product.

• Perform Supplier Quality Audits and participate as a lead or SME or equivalent experience in Corporate and/or Regulatory Body/Agency audits.

• Participate and have membership in trade and/or professional organizations to ensure that brand new industry standards are communicated into the division in an efficient, timely, and accurate manner.

• Provide technical support for complaint and adverse event review and investigation.

• Develop Quality indicators for new product launches and assure complaint metrics are supervised post launch.  Communicate complaint metrics back to the product development teams as part of awareness and continuous improvement.

• Work with manufacturing facilities, Durable Medical Equipment sites in the US (Liberator Medical and Tri-County Medical & Ostomy Supply), as well as in the UK and EU, and other Business Unit Facilities as required.

• Serve as an Independent QA Reviewer for Design Reviews, Design History File Audits (DHFa) and data integrity audits

• Participate in worldwide business travel as required by the above duties and responsibilities.

• Lead Quality Engineers on the team to complete their duties including:

  • Lead in identification of device specific regulatory and performance standards that should be used in the formulation of the design input requirements.

  • Review and approve design input requirements.

  • Review and approve the translation of design input requirements into design output documents.

  • Lead in Development of Risk Management Documentations.

  • Review and approve design verification and validation protocols and reports to demonstrate that the design output fulfills the design input requirements.

  • Support supplier validations.

  • Develop and approve test plan for demonstrating conformance to specifications and establishing controls.

  • Prepare and implement Reliability protocols and reports

  • Review and approve IQ, OQ, and PQ protocols and final reports.

  • Develop, review, and approve Test Methods.

  • Lead post launch quality review.

  • Handle the Master Validation Plan (MVP) for projects.

Qualifications

Education

• BS/MS in engineering, science, or other relevant field.

Experience

• Minimum eight (8) years of experience in a regulated environment, with five (5) years of product design experience.

• Minimum of six (6) years supervision experience of engineers or other specialists.

• Capital system (electro-mechanical) experience preferred.

• ASQ Certification(s) preferred.

• Experience in writing protocols/validations and fundamental knowledge of validation principles.

Knowledge

• Knowledge and understanding of Document Control practices.

• Extensive knowledge of medical device regulation, industry or international standard, including management responsibility.  Ability to understand Business Unit and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.  Ability to collaborate with regulatory bodies to present technical information.

• Extensive knowledge of quality systems and relationship to business.

• Understanding of applied statistics, statistical sampling plans, and statistical process control.

• Broad knowledge of manufacturing processes.

Requirements

Abilities

• Strong Verbal, written communication, and presentation skills.

• Strong Technical writing skills.

• Ability to serve in leadership roles on projects or assignments.

• Comprehensive understanding of auditing principles and ability to perform as a lead auditor.

• Ability to participate and provide leadership on teams and maintain positive work environment with those teams.  Understanding of team functions, leadership techniques and project management methodologies. 

• Ability to successfully lead time and handle multiple task assignments.

• Detail oriented and ability to organize large amounts of work and data.  This includes the need for good documentation practices.

• Plans efficiently and team oriented. 

Travel

• Ability to travel up to 25%.

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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