Quality Assurance Leader: Drive Compliance & Excellence

332 Merit Medical Nederland B.V.; Maastricht; On-site; EUR 90,000 - 130,000; Full time

Job summary

Merit Medical Nederland B.V. is seeking a Quality Assurance Manager to lead quality engineers, technicians and QA auditors. You will provide direction to ensure products meet required regulations, standards and specifications.

The role requires overseeing quality systems, risk management, budgeting and cross-functional support to operations, with a strong emphasis on problem solving and compliance in a regulated medical device environment.

Qualifications

• Bachelor’s degree in Engineering or related field with ten years of related experience and proven management skills.
• Ability to independently apply analytical skills, complex scientific principles, and detailed engineering knowledge.
• Knowledge of supervision principles and delegation of tasks.
• Demonstrated interpersonal skills and ability to manage a team.
• Working knowledge of US and international standards applicable to QA/Regulatory.

Responsibilities

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

Skills

QA Leadership

Regulatory Compliance

Quality Systems

Risk Management

Analytical Skills

Budget Management

Team Supervision

Education

Bachelor’s Degree in Engineering or related field

Tools

Oracle database

Excel

Word Processing

Database & statistical software

Job description

Merit Medical Nederland B.V. is seeking a Quality Assurance Manager to lead quality engineers, technicians and QA auditors. You will provide direction to ensure products meet required regulations, standards and specifications.

The role requires overseeing quality systems, risk management, budgeting and cross-functional support to operations, with a strong emphasis on problem solving and compliance in a regulated medical device environment.