Director, Quality Engineering

Overview

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose. We focus on developing transformative solutions that turn dreams into possibilities. We are committed to a high-performance, supportive environment where you can learn, grow, and become your best self.

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.

• 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, 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.

• Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Industrial) or a related scientific discipline required. Master's degree preferred.
• 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:
  
  Ability to lead, motivate, and develop high-performing teams. Excellent interpersonal and communication skills.
• Problem-Solving:
  Strong analytical and problem-solving skills with a data-driven approach to decision-making.
• Certifications (Preferred): ASQ certifications such as CQE, CQM/OE, or Six Sigma Black Belt.
• Technical Acumen:
  Strong understanding of medical device design, manufacturing processes, and related quality challenges.

BD prioritizes on-site collaboration to foster creativity and effective problem-solving. A minimum of 4 days in-office per week is typical for many roles, with flexibility and work-life balance considered. Remote or field-based arrangements will be indicated in the job posting.

For certain roles, employment may require proof of full COVID-19 vaccination. In some locations, testing may be available or required. BD’s Workplace Accommodations Policy provides for accommodations pursuant to applicable law.

At BD, you’ll be part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and improvement every day. We foster a culture where you can learn, grow, and thrive while helping to reinvent the future of health.

To learn more about BD, visit https://

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 status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Salary Range Information: $ - $ USD Annual