JD - Quality Engineer
Posted Updated
- Support the continual development, improvement, implementation and maintenance of the organization’s Information Security Management System (ISMS) and Quality Management System (QMS).
- Define, implement, review and maintain the organizational quality & information security policies, processes, procedures and controls in line with ISO 27001:2013, ISO 13485:2016 standards.
- Responsible for document and record control, review, issue, retrieval & superseding of all SOP and other.
- Collaborate with internal stakeholders for implementing controls and processes for respective functions and ensure continuous operating effectiveness of the defined procedures.
- Awareness of Medical Device standards & regulations - ISO 13485, ISO 14971, IEC 62304, SaMD, IEC 82304, CE, 21 CFR 820 – Design Controls, 510(k), MDR, TGA ARGMD and others.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Conduct / participate in Internal and External Audits.
- Coordinate and ensure timely closure of audit findings.
- Initiate and moderate the root cause analysis and monitor effective and timely implementation of CAPA.
- Analyze data to identify trends and opportunities for improvement on quality aspects.
- Conduct Information Security / Quality Management System Awareness and Training programs for employees as a part of their induction and regular awareness.
- Support on process improvement and continuous improvement activities.
- Drive process compliance in the complete lifecycle process of the medical device, mainly Software.
- Collaborate and consult product team members in implementing and realizing the processes.
- Collaborate and coordinate with cross functional team to review technical documents.
- Ensures product compliance with legal and normative requirements.
- Drive best practices within the organization