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BD (Becton, Dickinson and Company) Senior Quality Engineer (Validations) in Carol Stream, Illinois

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.

This position serves as principal Quality Assurance (QA) personnel to assist with implementing and maintaining the effectiveness of the Quality System. This position performs various quality-engineering functions and associated support tasks in driving business objectives, developing knowledge and experience in the areas of 21 CFR 820 and 803, ISO 9001-13485, and MDD/MDR. This includes working to support Design Control projects as well as other duties in support of the Quality System, Document Control, Manufacturing department, and Investigations (CAPA, Complaints, Nonconformance, and Unscheduled Maintenance).The position provides leadership and facilitation of Quality Management activities.

Job Responsibilities:

  • Provide leadership and support for quality objectives and process improvement efforts, serving as designee for the QA Manager, as necessary. Provide leadership and mentorship for Quality Engineers.

  • Oversees and is accountable for overall compliance administration activities relating to QSR, Design Controls, Validations/Qualifications, and CAPA.

  • Provides support for Project Teams or Quality Department as required.

  • Provides work direction as required.

  • Creates and reviews Quality System Documents.

  • Maintains the Validation Master Plan.

  • Builds/reviews Protocols, Process and Product Validations, Test Methods.

  • Creates and reviews documents required for Design Master File.

  • Creates and reviews Risk Assessments such as FMEA or FTA.

  • Lead, own, and/or provide guidance/mentoring for investigations (investigations pertaining to CAPA, Audit response(s), DMAIC/Failure Investigations, etc.)

  • Performs Internal and/or Supplier Quality System Audits.

  • Ensures compliance to Department and Division procedures.

  • Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.

  • Interfaces with other Division Facilities as needed.

  • Travels as required by the above duties and responsibilities.

  • Understand and follow the established corporate safety standard, local facility operating procedures and safety policies.

  • Maintain regular and predictable attendance

  • Other Duties may be assigned, including but not limited to:

  • General quality control / quality assurance

  • Product and raw material testing and release

Qualifications:

  • Proficiency in variety of Microsoft applications including Word, Excel, Visio, Powerpoint, and Minitab or applicable software.

  • Experience with regulatory and statutory agencies (FDA, Notified Bodies, etc.).

  • Experienced in Lean and Six Sigma methodologies.

  • Ability to lead teams and maintain positive work environment with those teams.

  • Strong technical and communication skills (verbal, written, and presentation).

  • Proficiency in internal and external (supplier) quality system auditing.

  • Ability to translate quality requirements into product specifications.

  • Ability to interpret Regulations, Corporate, Division and Department Procedures.

Education/Experience:

  • BA/BS in a scientific discipline (Engineering, Engineering Technology, Chemical/Biological or equivalent).

  • 3 years medical device / pharmaceutical experience;

  • 3 years of medical device /pharmaceutical validation, CAPA, complaint investigation, or quality system auditing experience.

  • Proven knowledge and experience in problem solving, validations, CAPA, and investigations (Failure, DMAIC, complaint, etc.).

  • Experience working with regulatory agencies (FDA, BSI, etc.)

  • Proficiency in Microsoft Word, Access and Excel

  • ASQ certification (CQE, CQA, etc…) preferred

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.

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Primary Work Location

USA IL - Carol Stream

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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