Manager, Quality Assurance

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

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 that budget.
• Resolves problems ensuring that quality needs are 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 their 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.