One of the most promising start-up companies in medical device industry is looking to hire a QA/RA Engineer in Singapore. This is an exciting opportunity to bring expertise and skills to an in-demand patient-centric medical technology company.
- Maintain and improve Quality Management System (QMS) to comply with ISO13485 certification requirements and US FDA QSR Regulations (Design Control) and ensure effective quality system in the company.
- Plan and conduct internal audits and prepare the company for surveillance / certification audits by external auditors. Communicate audit findings to relevant stakeholders and ensure that there is proper closure.
- Support the engineering team in creation and maintenance of product Design History File (DHF).
- Assist in qualification of suppliers, equipment, processes, and parts to ensure that the products' suitability to its intended use.
- Gather, evaluate, and manage regulatory requirements for products regarding their intended countries/regions of sale.
- Act as liaison between company and regulatory authorities to ensure that products are manufactured and distributed in compliance with appropriate legislation.
Skills and Requirements
- Degree in science or engineering field.
- Trained / certified internal auditor as per ISO 13485 and/ or 21 CFR Part 820 regulations.
- Excellent verbal, written communication and detail oriented.
- At least 3 years of experience in a medical device / pharmaceutical industry and relevant experience in quality assurance management.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sean Haw at firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.