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Quality & Regulatory Executive

3 weeks ago

Batu Kawan, Malaysia V3BIO SDN BHD Full time

Develop and manage effective quality control processes
- Devising and reviewing specifications for products or processes
- To manage and lead risk management process in the organization
- Oversee and manage customer complaints
- Setting requirements for raw material or intermediate products for suppliers and monitoring their quality compliance
- Oversee all product development procedures to identify deviations from quality standards
- Approve the right products or reject defectives
- Keep accurate documentation and perform statistical analysis
- Proactively look for opportunities for improvement and develop new efficient procedures
- To manage overall compliance of products and organization towards regulatory compliance such as US FDA, MDR, MDA
- To oversee project and manage works undertaken on regulatory affairs matters including product registrations, QMS and product certifications and other regulatory compliance matters.
- Oversee and manage QMS function on document control and procedure reviews, developments, reports and other quality documents/records
- To support and conduct internal audits and support external audits
- To train relevant staff on skills such as basic statistics, process capability, DoE, RCA, sampling plan, that will help enhance skills of staff for improvement in their job performance.

**Requirements**:

- At least 3 years working experience in the filed of Quality Assurance/ Regulatory or Quality Management system
- Min Degree in Technical or Science field
- Knowledge of ISO 13485 and regulatory requirements for medical devices

**Job Type**: Permanent

**Salary**: RM2,400.00 - RM3,500.00 per month

**Benefits**:

- Health insurance
- Opportunities for promotion
- Professional development

Schedule:

- Day shift

Ability to commute/relocate:

- Batu Kawan: Reliably commute or planning to relocate before starting work (required)