BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Senior Quality Engineer in Franklin Lakes, New Jersey

Job Description Summary

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.

Job Description

BD in Franklin Lakes NJ is looking for a new Senior Quality Engineer to join our Hypo Sustaining Engineering team. This role will give you the opportunity to combine Design Control expertise, creative problem-solving approaches and strong analytical skills to improve the lives of many people. A very strong candidate would an experienced engineer (5+ years in medical device) who can work under general direction and independently develop solutions.

Working with the Sr. Quality Manager, you will be accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all regulatory requirement.

Primary Responsibilities and Duties

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

  • Proven problem solving skills utilized to make measurable improvements to BD processes and procedures

  • Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements

  • Is a team member representing Quality on new product development and sustaining engineering projects

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

  • Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training)

Qualifications:

  • Applies knowledge of applicable regulatory, Corporate and / or Unit requirements

  • Experience in design of experiments and statistics

  • Class II / III medical device experience preferred as well as knowledge of six sigma methodology

  • Knowledge of design control principles with the ability to support Quality Systems audit

  • Education/Degree: Bachelors Degree in a related field

  • Certifications: Certified Quality Engineer (preferred)

  • Experience: A minimum of 5 years proven experience is required

Design Control

  • Design Input

  • Design Output

  • Design Verification plans, protocols, and reports

  • Design Reviews

  • Design Validation

  • Design History File support

Change control

  • Assessment of Change Request (ACR) Responses

  • Risk Management

  • Process Validations

  • Identification of CTQ's

  • Unit Quality Independent Reviewer During Design Reviews

  • Handling of deviations and non-conformances

  • Test method validations

  • Supplier qualification

  • Software validations

  • Post Market Surveillance

  • Situation Analysis

  • CAPA – Root cause investigation and implementation of corrective / preventive actions

  • Proper Use of Statistics (Sampling Plans)

  • Advise on Regulations

  • Liaise with Manufacturing Plants

  • Provide functional support to cross-functional teams

  • Internal and external audits

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.

#LI-PRO

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.

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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