Associate Director, Quality Management

Quality Engineering Manager

This position manages and coordinates compliance of the Global Engineering and Product Development quality engineering functions. This position is responsible for providing 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 process and quality / compliance strategies.

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 Responsibilities :

Provide mentoring, leadership and guidance to the quality engineering staff and technicians whose function is to develop and optimize design control process, develop and validate new equipment and test methods, assess current or emerging quality and regulatory compliance gaps, control and resolve nonconforming issues and lead continuous efforts.

Perform aspects of management in the administration of the QA department which include goal setting, planning, organizing, direction, and evaluating direct reports.

Lead Quality Engineering support for design and changes including incorporation of new products into the product portfolio; responsible for Quality oversight for verification and validation activities.

Support submissions and renewals on International, CE, TGI, Japan, China, clinical studies, for PIVC products.

Provide leadership and expertise on a diverse scope of quality / compliance issues where analysis of data is required to draw conclusions, identify risks, and propose possible solutions.

Oversee International complaints and drive investigations and mitigation efforts along with developing complaint reduction goals for Int'l geographies.

Understand variances in clinical processes in Int'l geographies and obtain appropriate design inputs.

Apply appropriate Quality and Compliance principles, tools and techniques to develop and optimize systems that are aligned with the overall company strategy, Global Product Development, Quality Policy and Regulatory requirements affecting international market growth and continuous compliance improvements.

Establish key performance indicators for the Quality Engineering and ensure support of global business objectives.

Participate in training and provide input to training of other employees on division and corporate procedures and policies, technical and managerial skills.

Work with International teams to help with the development of annual international product lines and interpret regulatory requirements in the light of current guidance and international regulatory body field activity.

Work with cross functional U.S. and International teams to develop, adapt, and execute strategic quality plans for new product development, global product registration, manufacturing, supplier management and product / business acquisitions throughout multiple markets taking into specific cultural and regional considerations.

Interact with local regulatory agency and oversee test labs to ensure a smooth working relationship, and compliance to BD, FDA and international regulatory requirements during New Product Development, design transfer and global product registration.

Keep abreast of new methods and developments in the Regulatory and Quality fields and shares attained knowledge with cross-functional team members.

Ensure international vendor audits are performed per schedule and any deficiencies are resolved 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 level of internal and external quality.

Education and Experience :

B.S. degree in Mechanical or Biomedical Engineering or similar technical field or equivalent

A minimum of six (6) years relevant supervision experience

Experience in biomedical engineering standards and concepts

Experience working in cross-functional team environment and a multi-level corporate environment

Preferred qualifications include :

M.S. in Engineering or Life Sciences

CQE, CRE, CQA or CQM certifications

Knowledge and Skills :

Good management and strong communication, leadership, and decision making skills

Ability to handle a variety of projects and coordinate the efforts of direct reports at the same time

Ability to work with outside suppliers, medical and technical professionals

Ability to function in a team environment, and to work with all levels of employees

Ability to confidently deal with ambiguous issues and provide input towards suitable actions

Strong project management skills, and the ability to analyze and use technical data

Strong overall business acumen and ability to implement corporate and divisional strategy

Knowledge of FDA / GMP / MDD, ISO 13485, CFDA regulations and other recognized standard

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.

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.

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 UT - Salt Lake City

Additional Locations

Work Shift