Quality Assurance Manager – Medical Devices

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

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