Executive recruitment company Monroe Consulting Group Malaysia's Healthcare Division is partnered with a multinational medical device company. We are looking for a Quality System Specialist to maintain and improve the global quality system processes include Document Control, Change Control, Design Controls, Complaints, CAPA, Quality Non-Conformance process, Deviations, Supplier Management, Training Programs, eQMS Systems, Audits programs, and related sub-systems.
The opportunity is based in Malaysia with remote-work arrangement.
- Assists the quality system's administrative tasks, such as rerouting, reassigning, and amending eQMS records in accordance with procedures.
- Maintains global operating policies and procedures to ensure compliance to regulations / procedures and to drive business results.
- Establishes and integrates quality system processes with other quality systems and subsystems.
- Implements measures to monitor the effectiveness of quality system processes and drives improvement.
- Manages KPIs for applicable Quality System processes.
- Monitors applicable records to ensure targets (e.g. timeliness, quality, etc.) for records are met.
- Participates as a key member in both external and internal audits throughout the global organization.
- Creates and provides ongoing quality system element process and system training.
- Administers quality system processes, including approving extensions, reviewing investigations, conducting training and reporting KPI's.
- Facilitates the Review Board for applicable quality system processes, ensuring that significant and recurring issues are escalated to Management.
- Performs other work-related duties, as assigned by management.
- Bachelor's degree preferably Engineering or Science, is required.
- A minimum of 5 years of experience is required in Quality Systems, Regulatory, or Quality Assurance in medical devices/pharmaceutical or a related field with 3 years of demonstrated leadership capability.
- Demonstrated ability to influence, organize and motivate cross-functional teams at all levels in the organization to meet quality and compliance goals.
- Knowledge of regulatory requirements (FDA, ISO, EU MDD/ EU MDR, Canadian MDR, Japan PAL) and experience with external auditing bodies medical device auditing experience.
- Experience working with a global team.
- Ability to prioritize, direct, and manage multiple projects consisting of varying degrees of complexity.
- American Society for Quality or similar professional certification- preferred.
- Experience with medical devices company- preferred.
- Experience with the use of Statistical techniques and tools- preferred