Senior Quality Engineer (18 months contract)
About The Position
This role focuses on ensuring continuous compliance with regulatory standards, including FDA and Good Manufacturing Practices, across manufacturing processes. The Senior Quality Engineer will conduct internal and external audits, deliver training sessions on quality assurance procedures and regulatory requirements, and design and implement inspection and testing methods. They will also be responsible for stopping production processes when non-conforming product conditions are identified, investigating product and process failures, and collaborating with suppliers to resolve quality issues. Additionally, this role supports new product introduction and validation activities.
Requirements
- Bachelor’s degree in Engineering or related discipline.
- Minimum 5 years of experience in Quality Engineering or a related field.
- Knowledge of inspection methods in electromechanical and/or mechanical manufacturing.
- Experience applying quality tools such as statistical process control and root cause analysis.
- Experience working in a regulated manufacturing environment.
- Intermediate level of English.
Nice To Haves
- Engineering license (EIT or PE).
- Formal training or certification in Quality Assurance methodologies.
Responsibilities
- Ensure continuous compliance with regulatory standards, including FDA and Good Manufacturing Practices, across manufacturing processes.
- Conduct internal and external audits; deliver training sessions on quality assurance procedures and regulatory requirements.
- Design and implement inspection and testing methods, including statistical process control, to maintain product precision and reliability.
- Stop production processes when non-conforming product conditions are identified and initiate containment actions.
- Develop and maintain documentation for inspection, testing, and validation activities, ensuring traceability and compliance.
- Investigate product and process failures using structured problem-solving methods (e.g., root cause analysis) and implement corrective actions.
- Collaborate with suppliers to resolve quality issues, standardize inspection methods, and support vendor audits and performance improvement.
- Support new product introduction and validation activities, including product, process, and packaging validation.
Benefits
- Travel Percentage: 10%
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What This Job Offers
Job Type
Full-time
Career Level
Senior
