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BD (Becton, Dickinson and Company) Staff Quality Engineer - Medication Delivery Systems in Franklin Lakes, New Jersey

Job Description Summary

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.

Summary - Main Purpose of the Position

As directed by the Sr. Quality Manager, the Staff Quality Engineer I is 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 design control and other regulatory requirements.

Primary Responsibilities and Dutie s:

  • Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / confirmed results.

  • Track record of root cause determination and effective corrective / preventive action implementation.

  • Provides training for product development teams and continuous improvement team on best practices.

  • Conducts audits as member of a quality system audit team (e.g. SME, etc.)

  • Writes and leads risk management activities including risk management reports and risk analyses.

  • May perform other duties as required.

Position-Specific Overview: Position specific responsibilities include support of the following, however are not limited to:

  • Design Controls

  • 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

KSA Requirements (Knowledge, Skills, and Abilities):

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

  • Training in design of experiments and statistics. Class II / III medical device experience. Knowledge of six sigma methodology preferred. Knowledge of design control principles (preferred). Ability to support internal / external audits.

  • Typically requires a minimum of a Bachelor’s Degree

  • Certified Quality Engineer and Certified Quality Auditor (preferred).

  • A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.

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.

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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