We are the people who give possibilities purpose

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.

Job Description

The Sr. Quality Engineer is accountable for quality support for devices, products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes.

Responsibilities:

• Provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and industry standards.

• Support new product development and existing product sustaining activities to ensure work follows proper design
  control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development
  teams and identifying Quality needs, product improvements and customer requirements.

• Ensures adequate design control documentation and records are maintained to support life cycle of design history.

• Lead and supportnew product development execution ofdesign control and ensure tasks are completed adequately to include project planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and design history files and other activities as needed.

• Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an
  acceptable quality level during manufacturing with properly established product specifications.

• Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.

• Review and authorize Quality approval for new product and/or device design specifications including product
  performance specifications, test methods, acceptance criteria, and release.

• Support product and/or device continuous improvement initiativesby providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.

• Review and assess work performed by R&D and other BD business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.

• Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and
  Process Validation.

• Lead or participate in ISO 14971 Risk Management activities appropriate to the initiative or situation.

• Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customer
  input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with
  Manufacturing, Service, Engineering, Regulatory and Biostatics.

• Initiate Corrective and Preventative Action plans and perform efficacy follow up.

• Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and
  regulatory requirements.

• Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs
  and established Quality Systems.

• Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries.
  Support regulatory inspections as needed.

• Support activities relating to Field Corrective Actions, when needed.

• Provide guidance quality and training to other quality engineer to help increase knowledge of regulations and
  standards for Devices and Combination Products.

• Support remediation and regulatory requirements including MDSAP/EUMDR.

Required Qualifications:

• Bachelor’s degree in STEM and five (5) years of engineering experience within a regulated industry, OR

• Master’s degree in STEM and four (4) years of engineering experience within a regulated industry

Preferred Qualifications:

• American Society of Quality (ASQ) certification (CQE, CQA, etc)

• Experience in medical device industry

Knowledge and Skills:

• Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills.

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

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