Hobson Prior is immediately seeking a CQV Automation Engineer for a critical 6-month contract position, with a significant focus on needle assembly, inspection systems, moulding, and final assembly processes. This urgent role is based in Penang, Malaysia, and presents an exceptional opportunity for candidates with specialised experience in these key areas within the medical device industry.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- Rapidly develop and execute detailed validation protocols and summary reports for needle assembly, inspection systems, moulding, and final assembly processes, ensuring compliance with quality standards.
- Promptly oversee the approval of deviations and quality documentation, aligning with 21CFR820, ISO13485, and other pertinent guidelines, with a focus on needle assembly and inspection system qualifications.
- Lead product development and transfer activities with urgency, guaranteeing standards for needle assembly, inspection systems, and moulding processes are met.
- Swiftly manage verification & validation methods, test protocols, and statistical analyses, particularly tailored for needle assembly, inspection systems, and moulding procedures.
- Evaluate new and updated product designs for quality attributes, with a rapid turnaround on manufacturability and serviceability, especially for needle assembly and moulding.
- Establish and uphold quality systems that address the immediate needs of needle assembly, inspection, moulding, and final assembly operations.
- Any other assigned duties.
Requirements:
- Proven and immediate experience in quality roles specifically tied to needle assembly, inspection systems, moulding, and final assembly processes in the medical device sector.
- Mastery in Automation Equipment Qualification and Medical Device Test Method Validation (TMV), with an acute focus on needle assembly, inspection, and moulding practices.
- A solid grasp of Pharmaceutical GMP and Medical Device CFR 21 820 GMP, especially as they apply to needle assembly, inspection systems, and moulding.
- Proficiency in statistical analysis, with experience in Mini-Tab or similar QA tools, ideally applied to needle assembly and inspection systems.
- Outstanding communication and technical writing skills, with fluency in English; additional languages are a plus.
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.
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