Manager, Quality Assurance

Merit Medical Systems; Maastricht; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Merit Maastricht (The Netherlands) serves as the European Headquarters and Distribution Center of Excellence for Merit Medical Systems, Inc. The company designs and manufactures proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, including cardiology, radiology and oncology.

We are seeking a Quality Assurance Manager to lead quality engineers, technicians and QA auditors, ensuring products are manufactured to required regulations and

Qualifications

• Educational or work-related experience equivalent to a Bachelor's Degree in Engineering or related area, ten years of related experience, with proven management skills.

Responsibilities

• Ensures compliance with quality system regulations defined in 21CFR Part 820, ISO 13485:2003 and JPAL.
• Provides resources to meet department objectives and support operations needs.
• Removes barriers to achieve objectives and provides managerial/technical support.
• Manages department budget and ensures expenditures.
• Resolves problems to meet quality needs and manufacturing criteria.
• Coordinates re-work of nonconforming product and quality audits.
• Prepares written reports on quality status and identifies improvement opportunities.
• Coordinates Tech Team as required.
• Manages department personnel including hiring, training, evaluating, and scheduling.
• Reviews risk management files to identify and mitigate new or exceeded risks.
• Performs related duties as required.

Skills

Analytical skills

Supervision

Interpersonal skills

Attention to detail

Problem solving

Computer skills

Regulatory familiarity

Risk management

Education

Bachelor’s Degree in Engineering or related area

Tools

Oracle

Job description

Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

SUMMARY OF DUTIES

The Quality Assurance Manager is responsible for providing management support, direction and leadership to quality engineers, technicians, and QA auditors, and provides technical support to ensure product is manufactured to the required regulations, standards and specifications.

DUTIES & RESPONSIBILITIES

• 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

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.

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 a domestic and international sales force and clinical support team totaling in excess of 500 individuals.

Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

UNDERSTAND. INNOVATE. DELIVER. Merit Medical 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 has made it a priority to understand customers, innovate, and deliver life-changing products and services.