Jobs / other
Quality Assurance Manager
Merit Medical · Venlo
IND sponsor
What you will do
- Takes ultimate responsibility for the direction and effective management of assigned departments within the quality assurance function, ensuring that each department is resourced, structured and managed to support the goals of the organization
- Provides input regarding Quality Assurance Program strategy for the site and meets the required regulations applicable to the processes managed, products produced, and global markets served.
- Key member of Senior Leadership Team that manages, develops and drives Merit Medical Systems Inc. to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development.
- Promote, support the Merit “HEART” Program; lead by example; partner with functional leaders to ensure that this program, the organizations objectives and values are at the forefront of decision making and action.
- Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction.
- Provides Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer
- Developing and directing annual ‘Quality Assurance” team goals to deliver the key company objectives and continuous growth of personnel.
- Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives.
- Preparing or reviewing written procedures and documentation for testing and manufacturing processes.
- Tracking information about customer complaints to provide design, development and operations teams with product quality information.
- Providing recommendations and decisions regarding the disposition of non-conforming products; determines when Regulatory/Clinical approval is required; stops production lines if problems with quality arise and initiates preventive and corrective actions to ensure non-recurrence.
- Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations.
- Smooth transition of new products and Technologies to operations groups
- Participate, support and provide independent review of all verification and validation activities.
- Functional & operational manager for a team of quality assurance personnel:
- Resource functional areas, projects with the required resources.
- Understanding of the roles of each member of the Quality function in order to drive process improvements.
- Maintains daily visibility on the shop floor to monitor processes, support employees, and identify quality risks.
- Select, coordinate assigned work, mentor, coach, manage performance for all team members ensuring appropriate corrective action for sub-optimal performance, and recognition of strong performance creating avenues for advancement.
- Manage training and career developmental needs of team to the benefit of the individuals and the organization, ensuring that talent is positioned and utilized for maximum effectiveness
- Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies
- Perform other related tasks as required.