Director, Quality Engineering
Not Disclosed•Full-TimeOn-site
location_onBig Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
About BD
We are the makers of possible. As one of the largest global medical technology companies, our Purpose is advancing the world of health™. It takes the imagination and passion of our global teams—from design and engineering to manufacturing and marketing—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element across our teams is what allows us to continually evolve. Join us to discover an environment where you will be supported to learn, grow, and become your best self.
About the Role
The Director, Quality Engineering will lead and strategically direct the quality engineering function, ensuring that the design, development, and manufacturing of medical devices meet the highest standards of safety, efficacy, and regulatory compliance. This role is crucial in driving a culture of quality throughout the entire product lifecycle.
You will partner with R&D, Manufacturing, Regulatory Affairs, and other departments to integrate quality into all aspects of product development and operations. Your day will involve developing comprehensive quality strategies, leading high-performance teams, overseeing design controls and risk management, and driving continuous improvement initiatives for manufacturing processes.
Our Work Culture
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.
A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. It is a place where we help each other be great, do what's right, hold each other accountable, and learn and improve every day. We welcome people with the imagination and drive to help us reinvent the future of health.
Equal Opportunity
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
Application Information
To find purpose in the possibilities, we need people who can see the bigger picture and understand the human story that underpins everything we do. To learn more about BD, visit bd.com.
Work location
Work model: On-site
Big Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
San Diego, California
Key Responsibilities
- check_circleDevelop and implement a comprehensive quality engineering strategy aligned with business objectives and regulatory requirements
- check_circleLead, mentor, and develop a team of quality engineers to foster a high-performance culture
- check_circleOversee the application of quality engineering principles in product design, including design controls and risk management
- check_circleDrive continuous improvement initiatives for manufacturing processes using root cause analysis and CAPA
- check_circleCollaborate with procurement and R&D to establish and maintain a robust supplier quality program
- check_circleEnsure all quality engineering activities adhere to applicable regulations and support internal and external audits
- check_circleProvide quality engineering support throughout the entire product lifecycle from concept to post-market surveillance
- check_circle
Requirements
- verifiedBachelor's degree in Engineering or related scientific discipline
- verifiedMaster's degree preferred
- verifiedMinimum 10 years experience in Quality Engineering in medical device industry
- verifiedAt least 5 years in leadership or management role
- verifiedIn-depth knowledge of FDA 21 CFR Part 820, ISO 13485, and international regulations
- verifiedProficiency in FMEA, SPC, MSA, Root Cause Analysis, CAPA, and statistical techniques
- verifiedASQ certifications (CQE, CQM/OE, or Six Sigma Black Belt) preferred
Nice to Have
Master's degree in Engineering or a related scientific discipline. ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Manager (CQM/OE), or Six Sigma Black Belt.
Similar Job Opportunities
Skills, education and keywords
Skills: Fda 21 CFR Part 820, Iso 13485, Fmea, SPC, Msa, Root Cause Analysis, Capa, Statistical Process Control, Six Sigma Black Belt, Certified Quality Engineer.
Education: Bachelor's degree in Engineering required; Master's degree preferred.
Frequently asked questions about Director, Quality Engineering at Becton, Dickinson and Company
What does a Director, Quality Engineering at Becton, Dickinson and Company do?expand_more
A Director, Quality Engineering at Becton, Dickinson and Company is responsible for the following: Develop and implement a comprehensive quality engineering strategy aligned with business objectives and regulatory requirements; Lead, mentor, and develop a team of quality engineers to foster a high-performance culture; Oversee the application of quality engineering principles in product design, including design controls and risk management; and Drive continuous improvement initiatives for manufacturing processes using root cause analysis and CAPA.
What are the requirements for this Director, Quality Engineering role?expand_more
To qualify for the Director, Quality Engineering at Becton, Dickinson and Company position, applicants should have: Bachelor's degree in Engineering or related scientific discipline; Master's degree preferred; Minimum 10 years experience in Quality Engineering in medical device industry; At least 5 years in leadership or management role; In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, and international regulations; and Proficiency in FMEA, SPC, MSA, Root Cause Analysis, CAPA, and statistical techniques.
Where is the Director, Quality Engineering role at Becton, Dickinson and Company located?expand_more
Director, Quality Engineering at Becton, Dickinson and Company is based in Big Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States. This is a on-site role.
Is this Director, Quality Engineering job remote, hybrid, or on-site?expand_more
Becton, Dickinson and Company has listed this Director, Quality Engineering role as on-site.
How much experience is required for this Director, Quality Engineering role?expand_more
Director, Quality Engineering at Becton, Dickinson and Company typically requires 10+ years of relevant experience at the executive level.
What skills do you need for the Director, Quality Engineering role at Becton, Dickinson and Company?expand_more
Key skills for Director, Quality Engineering at Becton, Dickinson and Company include Fda 21 CFR Part 820; Iso 13485; Fmea; SPC; Msa; Root Cause Analysis; Capa; and Statistical Process Control.
What education is required for Director, Quality Engineering at Becton, Dickinson and Company?expand_more
Educational requirements for this role: Bachelor's degree in Engineering required; and Master's degree preferred.
What category does the Director, Quality Engineering role belong to?expand_more
Director, Quality Engineering at Becton, Dickinson and Company is part of the engineering job category on Recrutus.