Job Information
BD (Becton, Dickinson and Company) Quality Engineer II in Franklin Lakes, New Jersey
Job Description Summary
Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Quality Engineer II for the Wearable Injector platform is responsible for supporting design control activities; responsible for problem-solving approaches and 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.
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
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Main Responsibilities:
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods process validation, 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
May provide guidance and work direction to other team members
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
Support supplier qualification activities – risk classification assessment and product quality assessments
Evaluate test methods used in project activities
Evaluation of customer requirements to identify applicable quality standards
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.
Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share
Support new customer onboarding activities – pre-feasibility and feasibility work
Position Requirements:
BS in Engineering or other scientific discipline
Minimum of 2 years of quality engineering or equivalent experience. 3-5 years industry experience (Medical Device and or Pharmaceutical) desirable
Understanding of industry regulations/ Standards: ISO 13485, 21 CFR 820, GMP, ISO 14971
Knowledge of design controls
Prior experience with Process Validation and Risk Management required.
General working knowledge of the six-sigma process methodology
Good written and oral communication skills
Excellent problem solving and analytical skills
Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project
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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.