Director, Quality Engineering

RXinsider LTD.; San Diego (CA); On-site; USD 179,000 - 323,000; Full time

Job summary

Becton, Dickinson, and Company (BD) seeks a Director of Quality Engineering to lead the quality function across design, development, and manufacture of medical devices, ensuring safety, efficacy, and regulatory compliance.

The role requires strategic leadership, hands‑on expertise in quality systems, and a track record of driving CAPA, risk management, and supplier quality across product lifecycles.

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline.
• Minimum 10 years of progressive experience in Quality Engineering within the medical device industry.
• 5+ years in a leadership or management role.

Responsibilities

• Develop and implement a comprehensive quality engineering strategy aligned with regulatory requirements (FDA 21 CFR Part 820, ISO 13485).
• Lead, mentor, and develop a team of quality engineers in a high‑performance culture.
• Oversee design quality assurance, design controls, risk management, and design validation activities.
• Drive continuous improvement initiatives for manufacturing processes using CAPA and SPC.
• Collaborate with procurement and R&D to establish supplier quality programs and audits.
• Ensure regulatory compliance and prepare for internal and external audits.
• Provide quality engineering support throughout the product lifecycle, from concept to post‑market surveillance.
• Partner with R&D, Manufacturing, Regulatory Affairs to integrate quality into development and operations.
• Establish and monitor key quality metrics and report to senior leadership.

Skills

Quality Engineering

Leadership

Problem Solving

Regulatory Knowledge

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

FMEA

SPC

MSA

CAPA

Job description

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Job Summary

The Director, Quality Engineering will lead and strategically direct the quality engineering function, ensuring 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 product lifecycle.

Job Responsibilities

Strategic Leadership

Develop and implement a comprehensive quality engineering strategy aligned with business objectives and regulatory requirements (e.g., FDA, ISO 13485).

Team Management

Lead, mentor, and develop a team of quality engineers, fostering a high-performance culture and ensuring effective resource allocation.

Design Quality Assurance

Oversee the application of quality engineering principles in product design and development, including design controls, risk management, and design validation activities.

Process Quality Improvement

Drive continuous improvement initiatives for manufacturing processes, identifying and addressing quality issues through root cause analysis, corrective and preventive actions (CAPA), and statistical process control.

Supplier Quality Management

Collaborate with procurement and R&D to establish and maintain a robust supplier quality program, including supplier selection, auditing, and performance monitoring.

Regulatory Compliance

Ensure all quality engineering activities adhere to applicable regulations and standards, preparing for and supporting internal and external audits.

Product Lifecycle Support

Provide quality engineering support throughout the entire product lifecycle, from concept to post-market surveillance.

Cross-Functional Collaboration

Partner effectively with R&D, Manufacturing, Regulatory Affairs, and other departments to integrate quality into all aspects of product development and operations.

Metrics & Reporting

Establish and monitor key quality metrics, providing regular reports to senior leadership on quality performance and trends.

Education

Job Qualifications

Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Industrial) or a related scientific discipline required. Master’s degree preferred.

Experience

Minimum of 10 years of progressive experience in Quality Engineering within the medical device industry, with at least 5 years in a leadership or management role.

Regulatory Knowledge

In-depth knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and relevant international regulations.

Quality Tools & Methodologies

Proficiency in quality tools and methodologies such as FMEA, SPC, MSA, Root Cause Analysis, CAPA, and statistical techniques.

Leadership Skills

Proven ability to lead, motivate, and develop high-performing teams. Excellent interpersonal and communication skills (written and verbal).

Problem-Solving

Strong analytical and problem-solving skills with a data-driven approach to decision‑making.

Certifications (Preferred)

ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Manager (CQM/OE), or Six Sigma Black Belt.

Technical Acumen

Strong understanding of medical device design, manufacturing processes, and associated quality challenges.

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. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting.

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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

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.

Primary Work Location

USA CA - San Diego TC Bldg C&D

Work Shift

At BD, we are strongly committed to investing in our associates—their well‑being and development, and in providing rewards and recognition opportunities that promote a performance‑based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field‑based and Remote roles.

Salary Range Information

$179,200.00 - $322,500.00 USD Annual