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BD (Becton, Dickinson and Company) Staff Quality Engineer II (Hybrid) in Franklin Lakes, New Jersey

Job Description Summary

Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Staff Quality Engineer II for the Wearable Injector platform will serve as a core team member, and is responsible for combining design control expertise, creative problem-solving approaches and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.

The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements.

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 creativity 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 entrepreneurial 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.

Main Responsibilities:

  • Evaluation of customer requirements to identify applicable quality standards

  • Serve as core team member

  • Release product during development activities

  • Realization of quality functional reviews

  • Ensure implementation of PS global procedures and standards for QE engineering activities

  • Provide support to internal, regulatory body and customer audits and associated corrective actions.

  • Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products

  • Consistent application of technical principles, theories, concepts and quality sciences / tools

  • Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

  • Contributes to the completion of specific programs and projects

  • Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers

  • Independently determines and develops approach to solution

  • May provide guidance and work direction to other team members

  • Designs and performs development working independently within defined parameters with minimal supervision required

  • Liaise with Manufacturing Plants

  • Provide functional support to cross-functional teams

  • Define product control strategy

  • Lead risk management activities

  • Ensure design control elements are satisfied

  • Ensure/ perform process validation activities

  • Develop/ perform supplier qualification plans have been defined and completed

  • Evaluate test methods used in project activities

  • Develop systems, processes, and procedures related to project quality activities.

  • Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share

  • Ensuring the terms on the agreement are met

  • Support customer facing teams by providing technical support from a quality perspective.

  • Share risk mitigation strategies and control plans for the device with the customers as applicable.

Position Requirements:

Education: BS degree in Engineering, or other scientific field

Experience: Quality Engineering experience or 12+ years industry experience (Medical Device/ Pharmaceutical)

Special Skills:

  • Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP

  • Knowledge of design control principles.

  • Thorough understanding of statistical methods for Quality Assurance

  • Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.

  • Knowledge and experience in manufacturing, project management and engineering.

  • Good written and oral communication skills

  • Excellent problem solving and analytical skills

  • Must possess excellent oral and written communication skills, and supervisory/leadership capability.

  • Ability to handle multiple projects simultaneously in an unsupervised environment.

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 encourage people with the creativity and aim 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.

PDN

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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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