Quality & Process Validation Manager

Description

Job Summary: We are seeking a Quality & Process Validation Manager to join a multidisciplinary team in the medical devices industry, ensuring compliance with regulatory requirements. Key Highlights: 1. Integrate into a multidisciplinary team in the medical devices industry 2. Develop qualification and validation protocols and reports 3. Opportunities for professional development We are looking for a **Quality & Process Validation Manager** to join a multidisciplinary team in the medical devices industry. This professional will be responsible for planning, executing, and documenting qualification and validation activities for manufacturing processes, ensuring compliance with international regulatory requirements and high standards of product quality and safety. The role requires strong analytical capability, technical knowledge in regulated environments, and experience with validation methodologies applied to the medical devices industry. **Key Responsibilities** * Develop qualification and validation protocols and reports: IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) * Execute validations of manufacturing processes, equipment, and associated systems. * Perform calibrations of monitoring and measuring equipment. * Ensure compliance with: ISO 13485 Good Manufacturing Practices (GMP) MDR 2017/745 * Participate in process transfers between development and manufacturing. * Define acceptance criteria and statistical validation strategies. * Support deviation investigations, CAPAs, and risk management. * Collaborate with teams including: Quality Supply Chain Regulatory Affairs Engineering Manufacturing * Conduct process capability analyses and statistical studies. * Ensure document control and technical traceability. * Participate in internal and external audits. **Desired Profile** **Academic Qualifications** * Bachelor’s or Master’s degree in: * Biomedical Engineering * Chemical Engineering * Industrial Engineering * Pharmacy * Or related fields. **Experience** * Minimum 1 year of experience in a regulated environment within the medical devices, pharmaceutical, or biotech industries. * Experience in process and equipment validation. * Knowledge of Lean and Six Sigma methodologies is an advantage. **Technical Skills** * Solid knowledge of: * ISO 13485 * Risk Management (ISO 14971) * Statistical tools applied to validation * Experience with technical documentation and change control. * Proficiency with tools such as Minitab or equivalent software. **Personal Skills** * High technical rigor and attention to detail. * Problem-solving ability. * Strong communication and teamwork skills. * Ability to manage priorities in a regulated environment. * Proactive profile oriented toward continuous improvement. **We Offer:** * Integration into a dynamic and growing company * Opportunities for professional development * Permanent employment contract * Health insurance * Birthday leave * Other benefits associated with the role If you believe you meet the described profile, please send your application to **recrutamento@ada.pt**, or share this opportunity with someone who may be interested! Compensation: €1,000.00 per month Benefits: * Internet access * Free parking * Health insurance Selection Question(s): * On a scale of 1 to 10, how would you rate your experience for this position? * Are you available to work on-site in Seroa (Paços de Ferreira)? Experience: * Quality & Validation: 1 year (Mandatory) Work Location: On-site