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BD (Becton, Dickinson and Company) Staff Quality Engineer I in San Diego, California

Job Description Summary

As directed by the Sr. Manager Quality Engineering, 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.

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.

Duties and Responsibilities:

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

  • Proven problem-solving skills

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

  • 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

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

  • May perform other duties as required

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

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

Strategic Orientation:

  • Develops advanced technological ideas and guides their development into a final product, process, or business opportunity.

  • Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work

  • Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context

  • Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives

Sphere of Influence:

  • Work is performed without appreciable direction.

  • Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results.

  • Plans and participates in disciplines strategically relevant to the business and/or functions

  • Provides advice and mentors junior Associates

  • Participates in, and may provide leadership for, multi-disciplinary projects

  • Considered Site / functional level Subject Matter Expert.

  • May be assigned as core team or extended core team member

Knowledge:

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

Skills:

  • Training and hands on experience in design of experiments and statistics.

  • Class II / III medical device.

  • Strong understanding and application of six sigma methodology preferred.

  • Extensive knowledge of design control principles.

  • Ability to support internal / external Quality Systems audit.

Education/Degree:

  • Requires a minimum of a Bachelor’s Degree in Engineering, Science, or mathematics.

Certifications:

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

Experience:

  • A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience in medical device or pharmaceutical industries.

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 CA - San Diego TC Bldg C&D

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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