Mantell Associates
Mantell Associates is partnered with an innovative Medical Device organisation, who are searching for an Interim Quality Operations Engineer. This opportunity is maternity leave cover for a 12 month period.
Reporting to the Quality Manager, your role is to ensure that the company’s organization complies with regulatory requirements.
Interim Quality Operations Engineer – Responsibilities:
- Participate in notified body audits and health authority inspections
- Carry out internal audits and supplier audits
- Participate in the development of qualification strategies, verify the relevance of tests, evaluate deviations, approve protocols and reports
- Analyze and evaluate customer complaints related to technical product failures
- Ensure the review and release of batch files, ensuring compliance with applicable controls
- Propose and implement the necessary curative, corrective and preventive actions
- Deal with deviations by carrying out and coordinating investigation and risk assessment procedures
Interim Quality Operations Engineer – Requirements:
- Higher education in science (Bac+5) as an engineer or pharmacist
- 5 years of experience in a similar role in a medical or pharmaceutical environment
- Experience in quality operations, with a focus on managing deviations in manufacturing processes
- Familiar with quality standards and practice root cause research and risk analysis methods
- You have mastered good manufacturing practices and are familiar with injectable products
- Ability to find solutions and make decisions to improve processes and address quality issues
- Proficiency in conducting reviews of modifications and synthesizing information to drive continuous improvement efforts
- Strong background in CAPA (Corrective and Preventive Actions) implementation and management
- Skilled in analyzing data and identifying trends to enhance quality control measures
- Fluent in French and English
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.