Director, Quality Engineering

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 Med Tech 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.

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.

Job Qualifications

Education

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…