Job Duties/Responsibilities:

• Provide leadership and support for quality objectives and process improvement efforts, serving as designee for the QA Ops Manager, as necessary.

• Provides technical input and leadership for projects using the application of FMEA’s, risk mitigation, plant validations, DOE’s and other experiments and investigations as assigned.

• Lead, own, and/or provide guidance/mentoring for investigations (investigations pertaining to CAPA, Audit response(s), DMAIC/Failure Investigations, etc.).

• Identify, implement, and monitor procedures and systems to support 21CFR§820, ISO 13485, and the European Medical Device Regulations.

• Creates/reviews Protocols, Process and Product Validations, and Test Methods.

• Creates and reviews Risk Assessments such as FMEA and/or FTA.

• Other duties as assigned

Qualifications:

• Proficiency in variety of Microsoft applications including Word, Excel, Visio, PowerPoint, and Minitab or applicable statistical analysis software.

• Experience working with regulatory and statutory agencies (FDA, Notified Bodies, etc.).

• Experience working with Lean and Six Sigma methodologies.

• Demonstrated time management skills.

• Ability to translate quality requirements into product specifications.

• Ability to interpret Regulations, Corporate, Division and Department Procedures.

Education and Experience:

• BA/BS in a scientific discipline (Engineering, Engineering Technology, Chemical/Biological or equivalent). 

• 3 years medical device, pharmaceutical experience or in a regulated industry is preferred..

• 3 years of medical device /pharmaceutical validation, to include manufacturing equipment/process qualifications (IQ, OQ, PQ) is preferred.

• Demonstrated knowledge and experience in problem solving, validations, CAPA, and investigations (Failure, DMAIC, complaint, etc.).

• ASQ certification (CQE, CQA, etc…) is preferred

• Advanced Statistics or Green/Black Belt / Six Sigma training highly desirable.

• Experience with Value Stream Analysis and LEAN Methods highly desirable.

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.