QA Product Release Section Manager

Grifols; Parets del Vallès; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

Jobtailor in Spain seeks a highly capable QA/Regulatory Affairs professional to lead product release activities, ensuring ISO13485/IVDR/MDSAP compliance and effective document control. You will coordinate with Notified Bodies, labs and health authorities, manage quality notifications, and drive continuous improvement within the QMS.

The role requires a Bachelor's in Engineering or Health Sciences, 3+ years in QA/RA, strong auditing experience, and excellent cross-functional collaboration and

Qualifikationen

• Experience in regulated environments under ISO13485 and/or IVDR.
• Experience in audits and supplier audits.
• Excellent communication across multiple departments.
• Attention to detail and compliance with regulatory standards.
• Analytical judgement in impact assessments.
• Cross-functional collaboration with engineering, QA, regulatory and supply-chain.

Aufgaben

• Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines.
• Participate in the configuration of systems related to product release.
• Coordinate communications with Notified Bodies, reference laboratories and related stakeholders.
• Manage documentation storage, control and retrieval, including externally archived documentation.
• Handle document management quality notifications, ensuring proper tracking and workflow.
• Approve quality notifications after evaluating their impact on batch release and product status.
• Monitor the status of materials affected by quality notifications.
• Coordinate communications with Health Authorities regarding import/export activities.
• Issue and manage authorizations and official letters required for import/export processes.
• Ensure compliance with ISO 13485, IVDR and MDSAP.
• Act as internal auditor and participate in supplier audits.
• Participate in continuous improvement of the Quality Management System.

Kenntnisse

Team management

Auditing

Quality assurance

Regulatory affairs

Communication skills

Attention to detail

Analytical ability

Cross-functional collaboration

English (C1)

Ausbildung

Bachelor's Degree in Engineering

Bachelor's Degree in Health Sciences

Jobbeschreibung

Responsibilities

• Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines
• Participate in the configuration of systems related to product release
• Coordinate communications with Notified Bodies, reference laboratories and related stakeholders
• Manage documentation storage, control and retrieval, including externally archived documentation
• Handle document management quality notifications, ensuring proper tracking and workflow
• Approve quality notifications after evaluating their impact on batch release and product status
• Monitor the status of materials affected by quality notifications
• Coordinate communications with Health Authorities (e.g., AEMPS) regarding import/export activities
• Issue and manage authorizations and official letters required for import/export processes
• Ensure compliance with applicable regulations such as ISO 13485, IVDR and MDSAP
• Act as internal auditor and participate in supplier audits
• Participate in continuous improvement of the Quality Management System.

Requirements

• Bachelor's degree in Engineering, Health Sciences or similar
• At least 3 years of experience in Quality Assurance or Regulatory Affairs
• Experience in regulated environments under ISO13485 and/or IVDR
• Experience in team management
• Experience in audits
• Excellent communication skills
• Cross-functional and collaborative work with multiple departments
• Attention to detail and compliance
• Analytical ability and technical judgement in impact assessments
• English level is C1.

Certifications & Qualifications

• Bachelor's Degree in Engineering
• Bachelor's Degree in Health Sciences