Quality & Process Validation Manager

Description

Job Summary: We are seeking a Quality & Process Validation Manager to join a multidisciplinary team in the medical device industry, ensuring compliance with regulatory requirements. Key Highlights: 1. Integrate a multidisciplinary team in medical devices 2. Develop and execute qualification and validation protocols (IQ, OQ, PQ) 3. Professional development opportunities We are looking for a **Quality & Process Validation Manager** to join a multidisciplinary team in the medical device 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 device 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 from: 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 medical devices, pharmaceuticals, or biotech. * 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 in 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 * Professional development opportunities * Permanent employment contract * Health insurance * Birthday leave * Other benefits associated with the role If you believe you meet the above 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 and Validation: 1 year (Mandatory) Work Location: On-site