QMS Engineer (RE-33765514)
Leading medical devices company looking for a QMS Engineer in the team. With a plan to build up their capability, the company offers exciting opportunity to their employees.
- Support the project or any initiative related to quality management system improvement and quality awareness.
- Ensures external and internal audit readiness and provides support during external and internal audits
- Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to regulations and other Regulatory Agency and consensus standard requirements
- Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes; monitoring and assurance of process performance
- Represents QMS/Engineering Change processes and records to regulatory agencies as required
- Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule
- Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities
- Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure
- Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development
- Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team
- Minimally years work experience in similar function in medical devices industry.
- Degree in related field.
- Familiar with ISO13485, 21 CFR 820 and other applicable local regulations.
Real is a trading division of SThree Pte Limited
(Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
As per Ministry of Manpower (MoM) requirements, if you're suitable for any roles that we will be putting you forward for, we will need to request for your identification number. Please be assured that this will not be disclosed with our client or any other parties other than MoM.
Award winner of:
Recruitment Agency of the Year by Asia Recruitment Awards 2019 | Best Overseas Operation by Global Recruiters 2017 | Highly Commended for Best Large Recruitment Business 2017 | Commended for Best In-House Training by Global Recruiters 2017 | International Recruitment Company of the Year by Recruitment International 2016 | Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016