QA Executive, Document Controller

1 week ago


Klang, Malaysia Wear Safe (Malaysia) Sdn Bhd Full time

**Qualification / Experience**

Minimum diploma holder and preferable with bachelor degree education level.

Minimum 2 years of working experience as a QA Officer or Executive related in document control, preferably in an established manufacturing environment.

Familiar with GMP requirement and Quality Management Systems (QMS) in relevant standards of ISO 9001& ISO 13485.

Knowledge in regulatory requirement such as FDA QSR, Malaysia Medical Device Act, EU Medical device Directives, EU Medical Device Regulation, EU Canadian MDR, Japan MHLW, Korean FDA, etc.

**Responsibility**

Responsible for Document Control Center, including document and record archive room, retention and disposal upon reaching retention period.

To ensure all controlled documents are well maintained and distributed to relevant personnel or departments.

To support External Audit such as QMS Audit by certified body, Customer Audit and regulatory audit.

To generate or revise standard operating procedures, work instructions and Quality records as necessary.

To prepare and update Document Master Record (DMR) as per FDA requirement.

**Job Types**: Full-time, Permanent

**Salary**: RM3,000.00 - RM4,000.00 per month

**Benefits**:

- Free parking
- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development

Schedule:

- Day shift
- Fixed shift

Supplemental Pay:

- Performance bonus

Ability to commute/relocate:

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

**Education**:

- Bachelor's (preferred)

**Experience**:

- total: 2 years (preferred)


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