In this role, you will lead and support validation and risk management activities across internal and external operations, helping ensure compliance with FDA and ISO requirements while driving continuous improvement initiatives.
You will be responsible for managing validation programs, maintaining risk management documentation, supporting audits, and collaborating closely with cross-functional teams to ensure high standards across systems, products, and processes.
This position requires a strong combination of technical expertise, analytical thinking, organizational skills, and the ability to manage multiple priorities in a fast-paced and highly regulated environment.
Success in this role means becoming a trusted subject matter expert for validation and risk-related activities, driving projects forward with a high level of ownership, maintaining strong collaboration with internal and external stakeholders, and ensuring compliance and operational excellence across validation processes.
What you will do:
Lead the creation of high-level test plans, validation assessments, and validation plans, while overseeing execution progress and completion.
Review and approve test methods, validation test plans, and validation results.
Manage validation samples and support validation execution activities across internal and external operations.
Serve as a point of contact for subcontractor test laboratories and support coordination of validation-related activities.
Maintain and regularly update pFMEA documentation and related risk management records.
Identify risks, support mitigation planning, and implement actions to maintain compliance and process reliability.
Support and conduct internal audits according to the annual audit program and report audit findings.
Manage relevant Issues, NCMRs, and CAPAs related to validation and quality activities.
Serve as a Subject Matter Expert (SME) for validation activities during internal and external audits.
Support continuous improvement initiatives related to systems, products, services, and validation processes.
Participate in and support calibration and preventive maintenance programs for measuring devices and test equipment, as needed.
B.Sc. degree in a scientific discipline or related Engineering/Science field, preferably Electronics, or equivalent practical engineering qualification in a relevant field.
Minimum of 3 years of experience as a Quality Engineer in a multinational medical device manufacturing and distribution environment.
Experience with qualification and validation of test methods, manufacturing processes, and related equipment used in validation, verification, or manufacturing activities.
Strong knowledge and practical use of quality tools such as Six Sigma, statistical techniques, sampling principles, risk assessment, and root cause analysis.
Six Sigma certification – an advantage.
Experience planning and overseeing product validation studies within the pharma and/or medical device industry.
Working knowledge of FDA medical device Quality Systems Regulations and strong understanding of quality regulations and standards, including 21 CFR 820, ISO 13485, and MDR.
Understanding of electro-medical devices and relevant regulations – an advantage.
Excellent English communication skills, both written and verbal.
Strong organizational and analytical skills with close attention to detail.
Ability to manage multiple projects and priorities simultaneously while interfacing effectively across all organizational levels.
