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BD (Becton, Dickinson and Company) Senior Quality Systems Engineer in Warwick, Rhode Island

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 is part of a group responsible for the implementation of the Surgery BU internal and external compliance audits process at Surgery BU locations. This includes the implementation, support, and maintenance of appropriate systems and documentation associated with internal, corporate, and external quality and compliance audits, associated training/education programs, quality system metrics, and opportunities for quality system improvements.

Essential Duties and Position Responsibilities

  • Supports the administration and implementation of the internal audit program at assigned Surgery BU location(s) on a timely basis to ensure compliance with appropriate standards and regulations including but not limited to FDA, ISO 13485, MDSAP, EU MDR for the development, manufacture, release, distribution, and support of products.

  • In coordination with Surgery BU quality management define and execute internal audit program criteria, scope, and audit plan.

  • Plans, coordinates, and performs quality internal audit(s) as a Lead Auditor/Auditor on a timely basis. As required, lead a team of auditors.

  • Manage both internal and external audits in an audit software program, adequately document, track, and efficiently close audits. Ensure proper investigation tools are used, and adequate audit action plan and effectiveness verification checks are defined. Verify effectiveness of corrective and preventive actions.

  • Coordinate internal pre-and post-inspection/audit activities for FDA inspections, Notified Body and Corporate audits and other regulatory assessments, including scheduling, record review, training, logistics, etc. for assigned location(s). In conjunction with quality management, support the development of responses to audit nonconformities for review by senior management.

  • Coordinate activities with Surgery BU locations to collect compliance related data on monthly/quarterly basis and provide monthly tracking metrics.

  • Coordinates and/or assists the Surgery BU locations management with the assessment and prevention of high risk nonconformances identified within BD.

  • Analyzes processes identified as needing improvement and assist with identifying, and as applicable, implementing appropriate corrective or preventive actions.

  • Supports the QMS transition activities, performs assessments to new regulatory requirements (such as ISO13485:2016, MDSAP, EU MDR as applicable).

  • Performs all other duties and supports as assigned.

Qualifications, Knowledge, and Skills Required:

  • B.S. degree in Engineering or the Physical or Biological Sciences.

  • 5 years (4 with M.S. degree Engineering or the Physical or Biological Sciences) quality, compliance, and regulatory experience in the medical device industry. Combination product, regulatory requirements and/or pharmaceutical experience preferred.

  • Certified Quality Auditor (ASQ CQA, CBA or equivalent) - required

  • Experience performing audits as Lead Auditor required.

  • Experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals and combination products.

  • Knowledge and experience auditing QSR and ISO 13485 quality systems, along with CAPA and Root Cause Investigations required

  • Knowledge and experience auditing to EU and MDSAP countries requirements preferred.

  • Excellent verbal and written communication skills

  • Proven 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.

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.

#LI-PRO

Primary Work Location

USA RI - Warwick

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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