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BD (Becton, Dickinson and Company) Quality Systems Specialist - Woburn, MA in Woburn, Massachusetts

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.

Summary of Position with General Responsibilities:

The primary responsibilities center on being the site lead for CAPA, complaint analysis, audit preparation and execution and organization and analysis of quality metrics.

Essential Job Functions:

  • Execute and administer activities associated with Quality Systems requirements including, but not limited to, CAPA, investigations and remedial actions. Serve as site CAPA coordinator.

  • Oversee the corrective and preventive action system (CAPA) and analyzing the results of the implemented actions in order to verify that the realized solutions were effective and determine if the scope of the action is broad enough.

  • Maintain systems for tracking CAPAs and Audit findings and perform trending activities and provide information as appropriate to management.

  • Participates in CAPA Review Board meetings and takes the lead with other functional groups to determine root cause failure and implement actions to prevent recurrence.

  • Apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues. Document risk-based rationales as needed throughout the Quality Management System.

  • Partner with cross-site and cross-functional resources in the pursuit of continuous improvement, and provide quality systems guidance as necessary.

  • Conducts and participates in internal and external Quality System audits to assess the compliance with FDA regulations, ISO standards, EU MDR and any other international regulations and internal requirements.

  • CAPA and Audit results reporting, analysis and presentation of activities, and perform follow up and tracking of corrective actions taken.

  • Oversee and/or execute complaint investigations which include DHR review. Trend metrics and recommend action as necessary.

  • Maintain and adhere to departmental processes and systems to ensure regulatory compliance.

  • Complete mandatory training by established due dates.

  • Leads the generation, publishing, trending, and monitoring of Quality metrics, including Management Review.

Basic Qualifications:

  • Bachelors Degree in a Technical field required, Engineering degree preferred

  • 3+ years of proven experience in quality systems/engineering in the medical device, pharmaceutical or biotech industry.

  • Working knowledge and application of quality tools, methodologies and software (i.e. Is/Is Not Analysis, 5 Whys, Cause and Effect Diagram, Process Mapping, Pareto Analysis, Minitab, etc.) in the areas of investigations and CAPAs.

  • Applied knowledge of the requirements of FDA QSR , ISO13485:2016 and ISO 14971:2012 as well as a thorough working knowledge of all major global quality system requirements (US, EU, Canada, Japan, Australia) for medical devices.

  • ASQ CQA certification preferred.

  • Proficiency in common computer applications such as Microsoft Office (Excel, Word and PowerPoint).

  • Good interpersonal and team player skills including ability to inte ract with high degree of diplomacy with representatives from a variety of disciplines.

  • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.

  • Willing to accommodate some travel as needed

For many 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, weekly testing for COVID-19 may be available instead of vaccination. 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 expansive, 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 MA - Woburn

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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