About us :

Natec Medical is a globally integrated CDMO and OEM partner specializing in the end-to-end design,development, and high-volume manufacturing of minimally invasive interventional medical devices. With a strategic presence across six continents, we empower global healthcare brands by delivering sophisticated catheter technologies and life-saving components. Our commitment to excellence is defined by technical precision, manufacturing agility, and a relentless drive to set the highest quality standards in the interventional market.

About the Role :

The Quality Control Manager will be responsible for the overall management, coordination and performance of Quality Control activities covering incoming materials, in-process products and finished medical devices. The role will ensure that inspection, testing and product release activities meet Natec’s specifications, Device Master Record (DMR), Quality Management System and applicable regulatory requirements, including ISO 13485 and 21 CFR Part 820. The position will also play a key role in ensuring effective QC resource planning, timely product release, compliance and continuous improvement while working closely with Production, Quality Assurance, Engineering, R&D and Supply Chain.

Main Accountabilities

Quality Control

• Lead and oversee the Quality Control function, ensuring effective planning, prioritisation and execution of inspection and testing activities.
• Plan QC resources and capacity in line with production priorities, shipment requirements and quality risks.
• Oversee incoming, in-process and final inspection and testing activities to support timely lot release.
• Ensure effective identification, segregation, documentation and escalation of nonconforming materials and products.
• Ensure compliance with GMP, GDP, data integrity and cleanroom requirements across QC and relevant production areas.
• Review and approve QC inspection and test plans for new products, transfers and process changes in collaboration with Quality Engineering, R&D and Production.
• Provide signature authority for Certificates of Conformity and applicable lot release documentation, including relevant EO sterilisation release documentation.
• Support testing activities related to design verification and process revalidation.
  

Quality Management System

• Actively contribute to the implementation, maintenance, and continuous improvement of the Quality Management System in accordance with ISO 13485 requirements, ensuring effective application within their area of responsibility.

Leadership/Resource Planning

• sProvide direct leadership and operational management of the Quality Control function, ensuring the effective organization, prioritization, and execution of incoming, in-process, and final inspection and testing activities.
• Ensure adequate staffing, workload balancing, and competency coverage across QC activities and shifts.
• Be responsible for the development and performance management of QC personnel, promoting accountability, technical competence, discipline, and continuous improvement within the team.
• Work closely with Quality Assurance, Production, Engineering, R&D, and Supply Chain to align priorities and coordinate QC activities.

Training & Development

• Ensure that all Quality Control personnel are appropriately trained, qualified, and periodically requalified on applicable inspection and testing methods, procedures, equipment, GMP, GDP, and data integrity requirements.
• Identify competency gaps requiring additional training, coaching, or requalification.
• Ensure that training and qualification records are complete, accurate, and maintained in accordance with the Quality Management System, and identifies competency gaps requiring additional training, coaching, or requalification.

Compliance

• Ensure that all Quality Control activities are conducted in full compliance with Natec’s Quality Management System, the Device Master Record (DMR), approved procedures and specifications, and applicable regulatory requirements, including ISO 13485 and 21 CFR Part 820.
• Ensure that incoming, in-process, and final inspection, testing, documentation, and release activities comply with GMP, GDP, and data integrity requirements.
• Support internal audits, customer audits, Notified Body audits, and regulatory inspections.

Budgetary Responsibility

• Responsible for the planning and management of the Quality Control budget (OPEX/CAPEX), including staffing requirements, inspection and testing equipment, laboratory consumables, external testing services, and investments required to maintain or improve QC capacity and performance.
• Ensure appropriate budget forecasting and expenditure control in alignment with operational needs and business priorities.

Qualifications & Experience

• A degree in engineering, materials science, mechanical engineering, or another relevant scientific or technical discipline is required.
• Training or certification in Quality Control, statistical techniques, metrology, inspection and testing methods, or medical device quality systems would be considered an advantage.
• Minimum 5 years of experience in Quality and/or Production within a highly regulated manufacturing environment, preferably in the medical device industry.
• Experience managing QC teams and inspection/testing activities.
• Experience in incoming, in-process, and final product inspection and testing, laboratory operations, QC resource and capacity planning, backlog management, and timely product release.
• Experience in supporting customer, Notified Body, and regulatory audits/inspections within a Quality Control environment is required.

Skills & Attributes

• Strong leadership and team management skills.
• Solid understanding of Quality Control principles and applicable quality and regulatory requirements, particularly ISO 13485 and 21 CFR Part 820.
• Strong knowledge of incoming, in-process, and final inspection and testing activities within a manufacturing environment.
• Good understanding of GMP, GDP, data integrity, and traceability requirements.
• Proficiency in statistical techniques, data analysis, and the use of tools such as Minitab or equivalent.
• Strong structured problem-solving and analytical skills.
• Ability to effectively plan resources, manage workload and capacity, establish priorities, and prevent or reduce QC backlogs.
• High level of rigor and attention to detail.
• Excellent written and verbal communication skills.
• Strong cross-functional collaboration skills.
• Ability to challenge, escalate, and influence effectively while maintaining the independence and integrity of the Quality Control function

How to Apply

Interested employees are encouraged to submit their applications by latest 15/11/2026.
Please include:

• An updated resume & motivation letter

Submit your application by e-mail to Dominique Aza: daza@natec-medical.com with subject ‘Quality Control Manager’ as e-mail subject.