Manager, Quality Assurance

• Ensures that quality system regulations defined in the Code of Federal Regulations – Quality System 21CFR Part 820, ISO 13485:2003 and JPAL are followed.
• Provides adequate resources to meet department objectives and support operations needs.
• Remove barriers which prevent objectives from being achieved and provide managerial and technical support helping others to achieve their assigned tasks.
• Provides input to the department budget and manages to that budget.
• Resolves problems ensuring that quality needs are bing met and manufacturing criteria are adhered to.
• Handles miscellaneous problems that arise, resolves problems with product quality and quality auditing procedures and coordinates the re-work of nonconforming product.
• Prepares written reports summarizing the quality status of product and systems and identifies opportunities for improvement.
• Assists and coordinates the Tech Team as required.
• Manages department personnel by interviewing, hiring, training, evaluating job performance, disciplining, scheduling work and other related responsibilities.
• Reviews risk management files to ensure new risks or risks that have exceeded there thresholds are identified and mitigated.
• Performs other related duties and tasks as required.

 
SUMMARY OF MINIMUM QUALIFICATIONS

• Educational and or work related experience equivalent to a Bachelor’s Degree in Engineering or related area, ten years of related experience, with proven management skills.
• Ability to independently apply analytical skills, complex scientific technical principles, and detailed knowledge in solving engineering problems.
• Knowledge of and ability to apply principles of supervision.
• Demonstrated interpersonal skills and the ability to delegate work.
• Attention to detail and good organizational skills.
• Problem solving and conflict management skills.
• Working knowledge of United States and international standards as applicable to the department.
• Demonstrated computer skills preferably spreadsheets, word processing, database (Oracle preferred), statistical analysis and other applicable software programs.

We are Global

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with an international sales force and clinical support team totalling in excess of 500 individuals. Merit employs approximately 6,300 people worldwide.

Merit Medical EMEA currently has over 300 employees, spread over more than 20 countries in the EMEA region.

Merit Maastricht (The Netherlands) is the European Headquarters and Distribution Center of Excellence. Much of Merit Medical’s world-class customer service happens here along with our excellent physician training courses. More than 100 employees work at this growing Merit campus and enjoy many benefits, such as flexible working hours and competitive salaries as well as learning opportunities and internships.

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with a 50/50 ratio of male and female employees and more than 30 nationalities. We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.