Quality Assurance Manager
Descrizione dell'offerta
Position: Quality Manager – Medical Devices / Conformity Assessment Body
Location: Primarily remote (with regular coordination meetings on-site and/or online)
Type: Full-time
About Certexe
Certexe is a newly founded Italian company, headquartered in Italy, on the path to becoming a CE Notified Body under MDR and IVDR. Joining us now means stepping in at the foundation phase, where your expertise will be key to achieving accreditation and building the systems that will support long-term international growth. We offer competitive compensation, flexibility, and the rare opportunity to grow with a Notified Body from start-up to international recognition.
About the Role
We are seeking an experienced and highly motivated Quality Manager to lead the development, implementation, and management of our Quality Management System (QMS) in accordance with applicable standards and regulatory requirements. In this strategic role, you will work closely with the Technical Director, Deputy Technical Director, and the management team to secure our initial MDR accreditation. Once accreditation is achieved, you will be responsible for maintaining, improving, and expanding the QMS to ensure compliance with ISO/IEC 17021, ISO/IEC 17065, ISO/IEC 17020, and other relevant schemes.
Key Responsibilities
• Lead the design, implementation, and management of the QMS to support accreditation as a Notified Body under MDR 2017/745.
• Prepare, maintain, and update quality documentation including manuals, procedures, work instructions, and records.
• Coordinate and support the organization in preparing for accreditation applications, assessments, and audits by regulatory and accreditation bodies.
• Ensure compliance with ISO/IEC 17021, 17065, 17020, ISO 13485, and MDR 2017/745.
• Manage internal audits, management reviews, nonconformity management, and corrective/preventive actions, driving a culture of continuous improvement.
• Serve as primary contact with accreditation bodies, regulatory authorities, and clients for quality and accreditation matters.
• Support the qualification and competence evaluation of internal staff, auditors, and technical experts.
• Monitor regulatory and standard updates to ensure the QMS remains current and effective.
• Contribute to strategic planning by shaping quality and compliance roadmaps.
Requirements
• University degree in Quality Management, Engineering, Sciences, Pharmacy, Medicine, or related fields.
• Proven experience as a Quality Manager or Quality System Manager within a Notified Body, Certification Body, Testing Laboratory, or similar Conformity Assessment Body, with direct involvement in accreditation processes under MDR 2017/745, ISO 17021, 17065, or 17020.
• Strong knowledge of ISO/IEC 17021, 17065, 17020, ISO 13485, and MDR 2017/745.
• Demonstrated experience in implementing, maintaining, auditing, and improving QMS processes.
• Excellent English communication skills (written and spoken), including technical writing and documentation.
• Strong organizational, leadership, and interpersonal skills with the ability to work independently and in cross-functional teams.
Highly Desirable
• Previous experience supporting a Notified Body through initial MDR accreditation processes.
• Certified Lead Auditor for ISO 13485 or ISO 9001.
• Experience in managing multiple accreditation schemes (MDR, IVDR, ISO 17021, 17065, 17020).
We Offer
• A strategic leadership role at the foundation of a new Notified Body, with direct influence on its future.
• Competitive salary and benefits designed to attract top professionals.
• Flexible, primarily remote working model with opportunities for international collaboration.
• The chance to shape and grow the QMS and accreditation scope of an organization from start-up to full recognition.
• A long-term career path in a dynamic environment where your expertise will define success.