BD (Becton, Dickinson and Company) Quality Engineer (Onsite) in New Jersey
Job Description Summary
This position is responsible for authoring, reviewing and approving QMS documents and records, as required, to support BD Delran plant quality objectives. This position will act as the quality representative regarding quality interests and concerns on project teams as well as getting involved in a variety of projects which may include, resolving quality problems, improving areas of high quality costs, assisting suppliers and subcontractors in meeting BD Delran’s needs. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.
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.
This position is located in Delran NJ
Relocation possible for the right candidate!
Benefits start on Day 1
Essential Job Functions:
Perform validations, including authoring protocols, in support of, but not limited to, new product development, process changes/improvements and test methods.
Provide technical support to ongoing/sustaining projects.
Design and conduct quality engineering studies for the following: to determine root causes of quality non-conformances, to initiate changes in process, tooling, and/or product design.
Initiate nonconformance reports, assures segregation and identification of rejected material, lead investigations and make dispositions of rejected nonconforming products; perform Material Review Board actions.
Develop documented instructions for performance of QC Inspections, including quality plans, inspection and test procedures and quality standards.
Review and approve incoming, in-process test inspection records and environmental monitoring records.
Review lot history record (LHR) documentation for completeness and compliance to quality requirements.
Review and approve customer specifications/requirements.
Perform customer complaint investigations.
Schedule and/or perform measuring and monitoring equipment calibrations.
Participate and perform in external and internal audits and inspections, as necessary.
Other projects, as assigned.
Knowledge and understanding of quality and manufacturing.
Knowledge of product development objectives and strategies.
Experience with statistical software such as Minitab and MS Excel.
Applied knowledge of FDA QSR and ISO13485.
Good oral and written communication skills.
Demonstrated ability to multi-task.
Good project planning skills and ability to meet internal/external customer needs.
Ability to work with and motivate people.
Additional Desirable Qualifications Skills and Knowledge:
American Society of Quality Certified Quality Engineer (ASQ CQE) preferred.
ISO-13485:2003 Audit training and/or American Society of Quality Certified Quality Auditor (ASQ CQA), a plus.
Six Sigma Green/Black Belt Certification or similar, a plus.
Software qualification, a plus
Experience with textiles, a plus
Education and/or Experience:
Bachelor’s Degree in Biomedical/ Engineering or related field.
Minimum of 2 years experience in medical devices and/or manufacturing environment, in a Quality Engineering role or equivalent.
Internal Relationships :
Quality Control Inspectors
Production and Warehouse Supervisors
Production & Warehouse Associates
External Relationships :
Functional and corporate management
Other Business Units
Regulatory Agencies and Notified Bodies
Industry peers and associations
Ability to lift approximately 25 pounds
Ability to stand long hours on the production floor and/or QC lab.
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 are an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on 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.
Primary Work Location
USA NJ - Delran
US BD 1st Shift 8am-430pm (United States of America)
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.