Identification de l’offre d’emploi R-432016 Date d’affichage 03/24/2022 Retour aux résultats de recherche Postuler

Staff Quality Auditor II

Job Description Summary

The Staff Quality Auditor II is responsible for performance of audits in support of the BD Corporate 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, he/she will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. He/she will maintain the audit database to monitor audit program metrics and prepare reports for management.

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 ambitious global health issues.

The Staff Quality Auditor II is responsible for performance of audits in support of the BD Corporate Quality Internal Audit program.   In this role, they is responsible for carrying out audits under the direction of the Associate Director Corporate Quality Audit. In addition, they will work with the sites to ensure submitted objective evidence is aligned with domestic and international regulations, corporate standards, and local procedures. They will maintain the audit database to monitor audit program metrics and prepare reports for management.

Primary Responsibilities and Duties

% of Time (estimated)

Responsibilities:    

  • 40% - Conduct Corporate Quality Internal Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.

  • 20% - Follow up with the auditee as required to compile information relating to the audits.

  • 15% - 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

  • 10% - Maintain the audit system software database to record the status of all audits and associated actions. 

  • 10% - Provide periodic reports to management based on the audit statuses and defined metrics.

  • 5% - Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.

  • May perform other duties as required

Scope of Responsibility:

Strategic Orientation:

This individual’s primary responsibility will be to perform quality internal audit of the various location’s Quality management systems which may result in identification of compliance risks that need to be addressed by the business to improve its compliance position and influence the quality strategy by the management team.

This individual will also be responsible for the execution of the department’s projects and strategic initiatives

Sphere of Influence a position influences and guides business activities, decisions and processes within a function or unit, as well as across organization boundaries. Interacting with individuals at various levels of the organization across multiple sites in performing audits at these assigned locations including top management.

Example of team(s) membership/leadership

Quality Audit Network

Corporate Quality Internal Audit  department

Audit Project Team Leader

Examples of internal (BD) contacts:

Personnel at all levels across the organization including Senior Management

Examples of external (outside of BD) contacts:

Consultant Auditors

Degree of Accountability:

Accountable for the overall execution of assigned audits per procedures, their interaction with all audit stakeholders, and their audit findings are supported by objective evidence rather than personal opinion and will be performing a process that is a requirement of maintaining a Quality system.

Financial Impact:

The key financial impact of this position is the potential to identify nonconformities impacting distributed product and may be subject to recall which indirectly may result in revenue loss and spending by the businesses to correct noncompliant systems.

Work Environment and Travel Required:

  • Work in an office setting and be physically able to travel domestically and internationally (Travel is 30-50%)

  • As part of audit, must be able to enter Laboratory and Manufacturing environments that may have specific PPE and health requirements.

Minimum Requirements:

Knowledge

  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation)
  • Experience interpreting and applying medical device regulations and quality industry standards including FDA QSR, ISO 13485, ISO 14971, MDSAP, and EU MDR, EU IVDR standards
  • Knowledge of other international medical device regulations preferred (e.g. China, Saudi, Korea, etc.)

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 crucial.

Education/Degree

Bachelor’s degree in Engineering, Chemistry, Biology, or other related field.

Certifications:

Must have Quality/Auditor Certification (or be able to renew/obtain) from a recognized organization:

  • American Society of Quality (ASQ; CQE, CQA, CBA, CMQ/OE, etc.)

  • Exemplar Global  ISO 13485 Lead Auditor Certification

  • IRCA ISO 13485 Lead Auditor Certification

Experience:

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.

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 based on 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

USA CA - San Diego TC Bldg C&D

Work Shift

Postuler

Lieu de l’emploi

Franklin Lakes

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Lieu de l’emploi

Franklin Lakes

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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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