Location: Belgium / UK
Salary- 75,000 euros
The Senior Principal Auditor will assist in the definition and implementation of the internal Audit Program. Responsible to assess compliance and the effectiveness of the Quality System against global internal and external regulatory requirements, policies, and procedures as applicable. Monitors internal audit schedule. Responsible to monitor and analyze regulatory agency and notified body trends and understand implications and direction of regulatory changes.
• Bachelor's degree in Life Sciences, Engineering, Medical or related field
• Lead auditor certification
• ISO13485:2016 training
• Training in IVDR or MDR, and 5 or more additional regulations
• 8-10 years of quality systems and GMP experience in the medical device, pharmaceuticals, or comparable environment
• Achieved recognized auditor certification from IRCA, RABQSA, or other government body
• 5 years of audit experience with a minimum of 20 audits with at least 8 as lead auditor
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Follows the Internal Audit Procedure.
• Develops, manages, and mentors other auditors.
• Responsible for collecting, interpreting, and applying regulations to maintain an effective QMS.
• Responsible for documenting, scheduling, planning, conducting, and reporting internal audits of site’s quality management system activities to assure compliance with applicable global regulatory requirements, global policies, and procedures.
• Responsible for management of Audit Teams.
• Responsible for managing projects and dealing with obstacles and changes while still accomplishing goals and objectives. Uses project management skills to conduct audits. Mentors Auditors in project management.
• Identifies, accesses, and analyzes all the internal and external data streams that have impact on the company's compliance to overall quality systems. Integrates data into our quality systems to create a clear, current, and accurate state of compliance. Strategically leverages information to assist in design of a robust global audit program. Charts data and makes recommendations based on areas of highest compliance risk.
• Connects well globally to understand changes in regulatory environment worldwide as it relates to the quality systems and adjust audit plans and approach accordingly. Identifies audit trends and anticipates future audit focus.
• Extensive knowledge of the FDA Code of Federal Regulations (21 CFR 820), applicable ISO standards (e.g., ISO 13485:2016, ISO 14971), MDSAP, MDR and/or IVDR, and other key relevant global regulations. Excellent verbal / written communication, interpersonal, and organizational skills; must be able to multi-task, assimilate, and analyze information quickly
• Computer skills required are MS Word, Excel, MS Outlook, Agile, and general database experience
• Strong project management skills
• Ability to analyze and evaluate unusual situations and make sound judgments
• Ability to maintain confidentiality
• Ability to keep integrity and high ethics
• Ability to accept constructive criticism
• Team player
Extensive travel may be required
If you are interested then please apply or email directly at firstname.lastname@example.org