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BD (Becton, Dickinson and Company) Staff Quality Engineer (Post Market) 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.

The Staff Post Market Surveillance (PMS) Engineer will collect, analyze, trend and report on safety data to proactively identify potential adverse safety risks or performance trends. Provides clinical and safety data assessment of post-marketing events. The incumbent will collaborate with cross-functional team members to ensure compliance to the applicable regulations, standards and company policies/procedures to help improve the lives of the people we serve by ensuring high standards of quality and safety of the medical devices being produced. Key Performance Indicator metrics are measured and analyzed for continuous improvement opportunities with subsequent action taken as appropriate. This position plays an integral role in maintaining compliance with global regulations.

Essential Duties and Position Responsibilities:

  • Work with PMS team to meet the requirements in generating PMS, Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER), Periodic Safety

  • Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) and related reports along with supporting the maintenance of appropriate Design History

  • File (DHF) documents such as Risk Management Files (RMF) spanning 3 facilities (Irvine, CA; Vernon Hills, IL; and Warwick, RI).

  • Mentor junior colleagues on PMS team to acquire skills to complete PMSPs, PSURs, and PMS Reports.

  • Identify development and training opportunities for PMS team along with Manager.

  • Leads local and global projects within the Surgery Quality team to align with BDX Quality and MDD/MDR strategies and regulatory submissions.

  • Identify gaps and maintain post market surveillance processes in compliance with global regulations.

  • Leads PMS/PSUR planning and reporting.

  • Assist complaint investigators, as needed.

  • Assist with Risk Management File Maintenance.

  • Position responsible for some regulatory reporting

  • Extract and generate PMS and operational performance data necessary for generating applicable reports.

  • Analyze and interpret clinical and PMS data.

  • Identify and raise instances when products are not achieving the intended

  • performance based upon anticipated levels of frequency and/or severity.

  • Identify and evaluate new failure modes when encountered.

  • Maintain procedures, as necessary.

  • Support responding to requests for additional information from competent authorities, registries and notified body.

  • Support internal and external audits.

  • Complete training by established due dates.

  • Identify and escalate quality issues as necessary.

  • Performs other related duties and responsibilities as assigned.

Skills and Experience:

  • Bachelor’s degree in a technical discipline required

  • Minimum 8 years’ experience with Bachelor’s degree or minimum 6 years’ experience with Master’s degree in the Medical Device field, and/or other regulated industry (Pharma, IVD) required

  • Sound working knowledge of regulations and industry standards consistent with requirements for a manufacturer of globally distributed medical devices and pharmaceutical products.

  • Strong computer skills and previous application of Microsoft Excel, Word, PowerPoint, Project, Visio, database management, statistical analysis and reporting packages.

  • Ability to acquire, query and analyze data with focus on detail.

  • Analytical skill and focus on detail.

  • Demonstrates strong attention to detail, able to identify missing information, and evaluate accuracy of presented information.

  • Demonstrates accuracy and thoroughness, applies feedback to improve performance, and monitors own work to ensure quality.

  • Good written and verbal communication, problem solving and applied thinking skills.

Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19.  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.

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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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