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BD (Becton, Dickinson and Company) Senior Manager, Quality Systems in Franklin Lakes, New Jersey

Job Description Summary

The Senior Manager, Quality Systems is directly responsible for managing the development, implementation, and improvement of the BD Medication Delivery Solutions (MDS) Franklin Lakes Unit Quality Management Systems. This position ensures that various Quality processes such as Internal Audits, Corrective & Preventive Actions, Non-conformance Reports, Training, Analysis of Data, Design and Development, Risk Management, Post Market Surveillance and Calibration are effectively implemented and comply with FDA Quality System Regulations, ISO 13485, MDD/IVD (MDR/IVDR), other MDSAP country regulations as well as any other applicable regulations/standards for MDS products. This role also manages external regulatory/ISO/NB inspections at the BD MDS Franklin Lakes location and supports the audits & inspections at the MDS manufacturing sites, Legal Manufacturers and Design Centers.

The Senior Manager, Quality Systems also supports the establishment and implementation of Global policies and procedures being harmonized as part of BD Inspire Quality program and provides guidance and training to MDS sites. This position also establishes and implements process for collection and analysis of quality data from the BD MDS sites. The Senior Manager, Quality Systems also support/represents the MDS Business in the BD Collaborative Community and Teams.

The Senior Manager, Quality Systems reports to the Sr. Director, Quality Systems.

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.

The summary below provides key responsibilities for the Senior Manager, Quality Systems:

  • Manages the various quality programs for the MDS Franklin Lakes Unit. These include CAPA, NCR/Deviations, Internal Audits, Quality Certificates, Training, Calibration, Analysis of Data, Design & Development, Post Market Surveillance, Risk Management, etc.

  • Collaborates with cross functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.

  • Manages the Internal Audit program for the MDS business. Ensures timely execution of planned audits, completion of corrective actions and closure of audits.

  • Hosts external regulatory inspections and audits. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management. Assists with FDA and external audit readiness at BD sites.

  • Ensures the CAPA Program is established and maintained.

  • Ensures that the training program is effectively implemented, and that appropriate training is assigned, provided and monitored to ensure Business training compliance goals are met.

  • Ensures that the NCRs and Specification Deviations are managed as per established processes and corrective actions are implemented in a timely manner.

  • Ensures that Risk Management and Post Market Surveillance programs are implemented effectively in compliance with applicable regulations and standards.

  • Establish and maintain processes to analyze Quality Data from MDS Sites.

  • Prepares for MDS Management Review.

  • Provide guidance and training to the MDS sites in various quality system areas such as CAPA, Internal audits, Analysis of Quality Data, Complaint Management, etc.

  • Supports company initiatives aimed at improving and standardizing the Quality Systems processes. Represents Businesses in BD Collaborative Community & Teams. Collaborates with the Business Group Quality Leads to seek their input and support in implementing the Global policies and procedures being rolled out as part of BD Inspire Quality program.

  • Manages and coordinates the Quality Systems staff. Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, promotions, salary actions, and processes performance reviews on time.

Qualifications:

  • BS in a related scientific or engineering discipline.

  • Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Manager) preferred.

  • At least 8 years of experience in Quality, Regulatory, or Operations of a Medical Device firm.

Skills:

  • Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD/IVD / EU MDR/IVDR, SOR/98-282, TG(MD)R, RDC 16, Ordinance #169, ISO 14971

  • Excellent communication skills at all levels both written and verbal.

  • Ability to set and deliver to specific goals and targets.

  • Ability to perform multiple tasks and prioritize work load.

  • Ability to organize and supervise people and activities.

  • Effective analytical, technical, and problem solving skills.

  • Effective meeting and presentation skills.

  • Effectively manage conflict.

  • Ability to work in or direct teams to obtain results.

  • Self-motivated /directed.

Other:

  • In-depth understanding of the application of quality systems to the medical device industry

  • Experience using Trackwise and SAP

  • Prior experience managing external regulatory audits 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.

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

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

NA (United States of America)

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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