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Staff Quality Auditor (BD's Quality Systems Internal Auditor) - Remote

Overview

Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health. At BD, you can make a true difference of one.

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Success Profile

What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Ambitious
  • Collaborative
  • Goal-Oriented
  • Persuasive
  • Results-driven
  • Self-starter

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A New Era in Healthcare

The complementary nature of BD and CareFusion capabilities make the new, combined company more relevant than ever before. It’s not just the solutions we offer, It’s also where we offer them. The global reach of the combined company can offer new solutions around the world.

Quote

Doug, Sr. Supplier Quality Engineer

"It has been great to see the effort that BD puts toward being inclusive and bringing the company together. BD has a wide variety of fun and interesting activities."

Jeffrey, Director / Quality Engineer II

"The culture is very good. Even though it's fast pace the crew are very supportive."

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Benefits

  • Healthcare

  • 401(k) / Retirement Plans

  • Professional Development

  • Paid Time Off

  • Awards & Recognition

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Responsibilities

Job ID R-359881 Date posted 02/14/2020

Job Description Summary

The Staff Quality Auditor is responsible for the performance of audits in support of the BD Quality Internal Audit program.In this role he / she is responsible for carrying out audits under the Direction of the Associate Director Corporate Quality Audit. In addition she / he will work with the audited sites to ensure submitted evidence is compliant with domestic and international regulations, corporate policies and procedures, and local procedures. She / he will maintain the audit database to monitor audit program metrics and prepare reports for management.

Job Description

Primary Responsibilities and Duties

  • Conduct Corporate Quality Internal Audits to assure compliance with domestic and international standards and regulations, corporate policies and procedures and local procedures.
  • Follow up with the audited site as required to compile information related to the audits
  • Evaluate the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management develop plans to address inadequate AAP documentation when required.
  • Maintain the audit system software database to record the status of all audits and associated actions.
  • Provide periodic reports to management based on the audit status and metrics.
  • Maintain a high degree of personal professional development through a combination of internal and external training and participation in professional associations as appropriate.
  • May perform other duties as required

Additional Requirements

  • Requires 30-50% domestic and international travel
  • Must be able to enter laboratory and manufacturing environments

Qualifications

  • Bachelor’s degree in Engineering, Chemistry, Biology, or other related discipline
  • A minimum of 5+ years work experience in the Quality organization of a Medical Device and/or Pharmaceutical company

  • A minimum of 3+ years experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.

Certifications

One of the below certifications or equivalent:

  • Certified Quality Auditor/ISO Lead Auditor Certified
  • Certified Quality Engineer
  • Certified Quality Manager

 Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred)

Knowledge

  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation)
  • Knowledge and ability to apply international regulations and standards of FDA QSR, ISO 13485, EU MDR, and ISO 14971 standards

Skills

  • Excellent verbal and written communication skills
  • Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical.
  • Strong analytical skills
  • Effective project management and organizational skills are essential.

***This position can be located out of any BD site in the United States.

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.

#LI-SMKT

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA CA - San Diego TC Bldg C&D, USA CA - San Jose, USA GA - Covington BMD, USA IL - Vernon Hills, USA MD - Baltimore, USA NC - Research Triangle Park, USA TX - El Paso - Northwestern Dr., USA UT - Sandy

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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