Identification de l’offre d’emploi R-435664 Date d’affichage 05/31/2022 Retour aux résultats de recherche Postuler

Quality Engineer (Validation Engineer)

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

This position as Quality Engineer assists 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.  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).

Job Duties/Responsibilities

  • Provide leadership and support for quality objectives and process improvement efforts

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

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

  • Identify, implement, and supervise procedures and systems to support 21CFR§820, ISO 13485, and the European Medical Device Directive.

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

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

  • Other duties as assigned

Qualifications

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

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

  • Experience working with Lean and Six Sigma methodologies.

  • Demonstrated time management skills.

  • Ability to translate quality requirements into product specifications.

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

Education and Experience

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

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

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

  • Proficiency in Microsoft Word, Access and Excel

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

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.

#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.

PDN

#LI-PRO

Primary Work Location

USA SC - Moncks Corner

Additional Locations

Work Shift

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Lieu de l’emploi

Moncks Corner

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Lieu de l’emploi

Moncks Corner

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«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
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