100 Merit Medical Systems, Inc. - South Jordan, UT
posted about 2 months ago
Full-time - Senior
South Jordan, UT
5,001-10,000 employees
About the position
The Quality Engineering Manager at Merit Medical is responsible for developing, interpreting, and implementing quality policies and managing quality systems to ensure compliance in new product development and design transfer. This role involves collaboration with various teams to revise the Quality Management System and keep abreast of scientific developments that may impact the organization. The manager will lead the Design Transfer process, manage regulatory agency interactions, and identify opportunities for process improvements to enhance product quality and customer satisfaction.
Responsibilities
- Develop and manage the Design Transfer process for new product introductions and acquisitions.
- Create capital plans and budgets for the Quality Engineering department.
- Act as the primary contact for regulatory agencies and customers regarding quality-related queries.
- Set strategies to ensure compliance with applicable regulations across global markets.
- Identify and implement improvements in organizational systems and processes to enhance efficiency and customer satisfaction.
- Provide recommendations to ensure quality products through effective management of non-conforming products and corrective actions.
- Support the manufacture of existing products and the development of new products in collaboration with R&D.
- Participate in verification and validation activities, providing independent reviews.
- Manage a team of Quality Engineering personnel, including mentoring and performance management.
- Ensure training and career development needs of the team are met.
Requirements
- Bachelor's Degree in Quality Engineering, Engineering, Science, Materials Science, Biomedical Engineering, or equivalent qualification.
- At least 15 years of work-related experience, with a minimum of 4 years in a similar role.
- Proven experience leading organizations through external inspections and audits (e.g., FDA, Notified Bodies).
- Working knowledge of U.S. FDA regulations and ISO standards relevant to medical devices.
- General knowledge of the medical device industry and applications of products.
Nice-to-haves
- Post graduate diploma/Master's degree in Quality Management.
- Experience with Lean and Six-Sigma methodologies.
- Medical device design and manufacturing management experience in global markets.
- Leadership experience in developing large, international teams.
Benefits
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
- 401K | Health Savings Account
