BD (Tissuemed Ltd) · 3 weeks ago
Associate Director, Quality Management
Salt Lake City, UT
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
6+ years expBD is one of the largest global medical technology companies in the world. This position manages and coordinates compliance of the Global Engineering and Product Development quality engineering functions, providing strategic direction regarding quality, regulatory and compliance issues.
Health CareHospitalMedicalMedical Device
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
Qualification
Required
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
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
Preferred
M.S. in Engineering or Life Sciences
CQE, CRE, CQA or CQM certifications
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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