Job ID R-411906 Date posted 10/12/2021

Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
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Responsibilities

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 purpose of this position includes specific focus in Quality Systems Improvement process including Corrective and Preventive Action (CAPA) process, and all phases of the CAPA process.  This associate owns and manages the performance of CAPAs, assists, coaches and mentor other personnel and company associates in the CAPA process including investigation tools, Root Cause Analysis tools, CAPA content, and guidance to be successful in the quality performance of their work.  Additionally, this Sr Quality Systems Engineer functions as a subject-matter resource for Quality Improvement Systems, and Quality Systems Requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Provides guidance on the application of investigation, root cause analysis tools, corrective actions, dissemination of CAPA findings, and statistical methods for use in effectiveness verifications to peers who own CAPAs or participate on CAPA teams.

  • Serves as Subject Matter Expert (SME) on CAPA process in cross-business unit network.  Uses objective data to influence cross-functional peers to align on standard methodologies within the network on process and system tools used to manage CAPA.

  • Performs data analytics around Quality system process (CAPA and similar) performance, and  prepares and presents metrics related to quality system elements, as needed (weekly, monthly, and quarterly) for senior management and / or required Quality systems reports.

  • Responsible to monitor the accurate completion of corrective action plans and to coordinate the reporting of CAPA and other Quality Management System process metrics (KPI) to Business Unit management during management reviews.

  • Champions continuous improvement and innovation from a quality perspective within the department.

  • Provide oversite and collaborate with Post Market Quality for timely completion of Non Conformance escalation process (Situation Analysis)

  • Provides leadership and guidance in the timely communication/escalation to the Quality Head and Senior Leaders of Business Unit issues associated with CAPA items.

  • Basic application of Quality systems principles and concepts (e.g. Document control, CAPA, or other broad Quality Systems area).

  • Implements solutions to routine assigned activities (e.g. Document change, CAPA documentation).

  • Analyzes process non-conformances and implements comprehensive corrective and preventive action plans.

  • Collaborates with members of the CAPA community from all sites to deliver process improvements for the global CAPA processes

  • Provides guidance for the development and maintenance of quality programs, such as processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).

  • Assists Compliance Manager with audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

  • Provides data input as requested to support post market surveillance projects.

  • Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the Business Unit in an efficient, timely, and accurate manner.

  • Represents the Corporation, Business Unit and Quality Department in a professional manner.

  • Performs data analytics and ensures the creation of report presentations for senior management.

  • Uses standard and approved Quality/Compliance methods (good documentation practices).

  • Provides work direction as required.

  • Creates, reviews, revises, and approves Quality System Documents.

  • Assists with special projects as assigned to support Quality.

  • Other duties as assigned.

EDUCATION and/or EXPERIENCE

  • A four-year degree in Engineering, Engineering Technology, Science, or equivalent.

  • Minimum 5 to 8 years of proven experience in engineering.

  • Experience in process improvement engineering or product / process improvement areas is preferred.

  • Experience in Quality function or with responsibility for ownership of quality system elements within role(s) is preferred.

  • Experience with Trackwise is a plus

  • Ability to function in a team environment and deliver on team objectives is required.  

  • Solid understanding of ISO Quality Systems Standards and Regulations (ISO 9001, 13485), FDA food, drug, or medical device regulations, or similar regulations from food, automotive, defense, safety or similarly regulated industry.  Must be able to understand and apply regulated principles in work experiences.

  • Working knowledge and understanding of QSR, ISO and EU MDR and other medical device industry quality requirements

  • American Society of Quality (ASQ) certification (CSQE, CQE, CQA, etc.) a plus/preferred

  • Certification in Lean Six Sigma, Green or Black Belt certifications is preferred.  Similar industry process improvement certification(s) may be used in lieu of Green/Black Belt certification.

QUALIFICATIONS

  • Understanding/experience with electronic corrective and preventive action systems documentation (eCAPA)

  • Must have previous experience in management CAPA processes in medical device, pharmaceutical, automotive, defense or similar regulated industries which utilize CAPA, 8D, other structured problem solving or similar processes to conduct process improvement activities in response to identified and / or potential nonconformances.

  • Ability to create and qualify pivot tables, pivot charts, macros, queries, forms, reports, etc. across applications.

  • Understands basic applied statistics. Can utilize basic statistical software tools with guidance on inputs from procedures for validation, sample size selection, data analytics.

  • Understands and can apply sampling methodologies for CAPA effectiveness checks.

  • Ability to ensure reports are delivered on time to all customers – senior management, Corporate management, and franchise teams.

  • Extensive knowledge of quality systems and relationship to business.

  • Understanding of auditing principles.

  • Ability to participate on teams and maintain positive work environment with those teams.

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 GA - Covington BMD

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)
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Advancing the world of health™

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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.


Zakiyyah Walker
Staff Engineer

Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.


Michael Carrano
Senior Program Manager

BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.


Justyna Zielinska
Project Manager

BENEFITS

Healthcare

Healthcare FSA

Employer Matching

Tuition Reimbursement

Professional Development

Maternity and Paternity Leave

Paid Time Off

Competitive Compensation

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