Automation Quality Manager

Hobson Prior is actively seeking a Quality Automation Engineer Manager for a 6-month contract role to join a leading client in the medical device industry located in Kerian District, Perak, Malaysia. This is an excellent opportunity for professionals with demonstrable experience in quality roles for medical devices.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Review and approve validation protocols and summary reports, ensuring alignment with regulatory requirements.
• Evaluate and approve deviations and other quality documents, ensuring compliance with 21CFR820, ISO13485, and other relevant guidelines.
• Lead in product development and transfer activities, aligning with industry and regulatory standards.
• Support and review verification & validation methods, test protocols, statistical analyses, and specification assignments.
• Evaluate new and modified product designs for quality characteristics such as manufacturability, serviceability, and conformance to product requirements.
• Develop and maintain quality systems, including SOPs, QA Manuals, client complaint management, CAPA, non-conformances, and deviations.
• Conduct Automation Equipment Qualification and Medical Device Test Method Validation (TMV), including measurements of parts and visual inspection.

Requirements:

• Demonstrable experience in a quality role in the medical device industry.
• Strong understanding of automated inspection systems, molding, and final assembly processes.
• Proficiency in Automation Equipment Qualification and Medical Device Test Method Validation (TMV).
• Excellent knowledge of Pharmaceutical GMP and Medical Device CFR 21 820 GMP, International Organisation for Standardisation (ISO).
• Strong statistical analysis skills; experience with Mini-Tab or similar QA tools is a plus.
• Excellent communication and writing skills.
• Languages: Proficiency in English is required; additional languages are an asset.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.