Quality Control manager

An international, global leading medical device manufacturer is looking for an experienced colleague in QC Manager position for its new start-up location in Hungary, Dunakeszi.

The Quality Control Manager is responsible for leading all QC activities (5 direct reports) across the Dunakeszi manufacturing site for steam and low temperature sterilizers. The role ensures that pressure vessels, incoming materials, in-process production, and finished products meet all required quality standards. The position is part of the Global Quality and Regulatory team and supports all necessary activities on site.


Key Responsibilities
1. QC Team Leadership

• Lead, train, and supervise the QC team for pressure vessel testing, incoming inspection, and production floor inspection.
• Ensure consistent of inspection procedures, documentation, and reporting.
• Align site QC activities with both site needs and global QA and RA requirements.

2. QC Inspection Plan Management
Improve product quality and ensure compliance with site and global expectations.
Actions:

• Manage and execute the QC inspection plan.
• Verify that inspection capacity meets site needs and aligns with operational requirements.
• Ensure all QC activities follow procedures and global standards.
• Provide weekly and monthly KPI reporting.
• Ensure timely and accurate documentation.

3. Right First Time Management
Improve product quality and reduce rework by ensuring processes produce defect-free units on the first attempt.
Actions:

• Establish a cross-functional RFT improvement team that includes Production, Engineering, and QC.
• Conduct weekly analysis of production lines to identify root causes and define actionable improvements.
• Integrate findings into RFT and NCR improvement initiatives.
• Present monthly reports during Quality Meetings with graphical trend analysis and AI-assisted insights.
• Provide weekly and monthly KPI reporting.

4. NCR and MRB Management
Lead and strengthen NCR and MRB management, investigation, and closure efficiency.
Actions:

• Lead and manage weekly MRB meetings.
• Strengthen investigation processes to ensure accurate root cause analysis and effective preventive actions.
• Provide weekly and monthly KPI reporting.

5. Support for Global Quality Assurance and RA Continuous Improvement and Compliance

• Support global and local quality improvement strategies and regulatory alignment.
• Ensure compliance with relevant standards and internal procedures.
• Provide quality insights to support decision making at the site leadership level.
• Lead and support audits, including preparation, on-site activities, and CAPA management. Audits include DEKRA (support), UL (lead), pressure vessel (lead) certification, and others as required.
• Support complaints investigation, training and qualification, CAPA activities, supplier management, management reviews, and additional quality tasks as needed.

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum of 3 years of QC or QA experience in a manufacturing environment, preferably in medical devices or capital equipment.
• Experience with NCR investigations, MRB processes, and quality systems.
• Strong leadership, analytical, and communication skills.
• Experience with root cause analysis tools and continuous improvement methodologies.
• Fluent English speaking and writing skills.

• experience in the manufacturing of medical devices

• Working for a growing international healthcare company with a stable background
• Career advancement opportunity
• Competitive compensation and benefit package, bonus
• Laptop, mobile phone
• Brand new, modern working environment
• Excellent working environment: good atmosphere, cohesive team, supportive and friendly colleagues
• Fruit days in the office
• Life insurance
• Free parking

After clicking the “Apply” button, please attach your CV in both Hungarian and English including your salary expectations.