Associate Director, Quality Management

Associate Director, Quality Management

BD Nogales Norte

This position manages and coordinates compliance of the Global Engineering and Product Development quality engineering functions. It provides strategic direction and support regarding Global Engineering and Product Development with respect to current or emerging quality, regulatory and compliance issues. Responsibilities include assisting in the development of tools or guidance documents to promote consistent implementation of product development processes and quality/compliance strategies.

• Provide mentoring, leadership and guidance to the quality engineering staff and technicians.
• Perform aspects of management in the administration of the QA department, including goal setting, planning, organizing, direction and evaluation of direct reports.
• Lead quality engineering support for design and change activities, incorporating new products into the product portfolio and overseeing verification and validation activities.
• Support submissions and renewals on international and regional regulatory bodies.
• Provide leadership and expertise on a diverse scope of quality and compliance issues, drawing conclusions from data analysis, identifying risks and proposing solutions.
• Oversee international complaints and drive investigations, mitigation efforts and develop complaint reduction goals for international geographies.
• Understand variances in clinical processes in international geographies and obtain appropriate design inputs.
• Apply quality and compliance principles, tools and techniques to develop and optimize systems aligned with company strategy, global product development, quality policy and regulatory requirements.
• Establish key performance indicators for the Quality Engineering team and support global business objectives.
• Participate in training and provide input to training of other employees on division and corporate procedures and policies.
• Work with international teams to develop annual product lines, interpret regulatory requirements and adapt to cultural and regional considerations.
• Work with cross‑functional U.S. and international teams to develop, adapt and execute strategic quality plans for new product development, product registration, manufacturing, supplier management and acquisitions.
• Interact with local regulatory agencies, oversee test labs and maintain compliance during new product development, design transfer and global registration.
• Keep abreast of new methods and developments in regulatory and quality fields and share knowledge with cross‑functional team members.
• Ensure international vendor audits are performed per schedule and resolve deficiencies in a timely manner.
• Develop plans and strategies to assure BD is successful in all compliance audits.
• Provide effective leadership, communication and training that will strengthen and continually improve company‑wide quality.

• B.S. degree in Mechanical or Biomedical Engineering or similar technical field.
• Minimum of six (6) years relevant supervision experience.
• Experience in biomedical engineering standards and concepts.
• Experience working in cross‑functional team environments within a multi‑level corporate setting.

• M.S. in Engineering or Life Sciences.
• Certifications such as CQE, CRE, CQA or CQM.

• Good management, communication, leadership, decision‑making and project management skills.
• Ability to handle multiple projects and coordinate efforts of direct reports.
• Ability to work with outside suppliers, medical and technical professionals.
• Strong business acumen and ability to implement corporate and divisional strategy.
• Knowledge of FDA/GMP/MDD, ISO 13485, CFDA regulations and other recognized standards.

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. 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.

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.

Location:

Salt Lake City, UT

Employment Type:

Full‑time

Seniority Level: Director

Job Function:
Quality Assurance

Industries:
Manufacturing