Quality Manager

1 week ago

Kulim, Malaysia Duramitt Sdn Bhd (GHH safety solution group) Full time

**Job Summary**:
**Key Responsibilities**:
**1. Quality Assurance**:

- Develop, implement, and maintain quality management systems (QMS) in accordance with industry standards and best practices.
- Oversee quality control processes to ensure product quality and safety.
- Manage and coordinate internal and external audits and inspections.
- Investigate and resolve quality issues, including root cause analysis and corrective actions.

**2. Regulatory Compliance**:

- Develop and maintain comprehensive knowledge of local, regional, and international regulatory requirements related to our products.
- Ensure all products comply with relevant regulations, standards, and guidelines (e.g., FDA, ISO, CE).
- Prepare and submit regulatory documents to authorities and maintain records of approvals.
- Monitor changes in regulatory requirements and implement necessary changes in company policies and procedures.

**3. Documentation and Reporting**:

- Ensure accurate and up-to-date documentation of regulatory and quality activities.
- Prepare and present regular reports on compliance, quality metrics, and improvement initiatives to senior management.
- Maintain detailed records of regulatory submissions, correspondence, and approvals.

**4. Cross-Functional Collaboration**:

- Work closely with R&D, manufacturing, marketing, and other departments to ensure regulatory and quality compliance throughout the product lifecycle.
- Provide guidance and support on regulatory and quality matters to internal teams.
- Coordinate with external partners, such as regulatory consultants and certification bodies.

**5. Continuous Improvement**:

- Drive continuous improvement initiatives to enhance quality and regulatory processes.
- Stay abreast of industry trends and regulatory updates to proactively address potential compliance issues.
- Promote a culture of quality and compliance across the organization

**6. Team Management and Training**:

- Lead the quality department team, develop training plans to enhance team members' professional skills and quality awareness, and foster a strong quality culture.
- Establish guidelines and control points for department personnel.
- Train and supervise department personnel to strictly follow quality management regulations and procedures.

**Qualifications**:

- **Educational Background**: Bachelor's degree or higher, preferably with science or engineering background or related fields.
- **Work Experience**: At least 5 years of relevant quality management experience, with over 3 years of management experience; experience in the protective gloves manufacturing industry is an added advantage.
- **Professional Skills**:

- Familiarity with ISO 9001 quality management system and other relevant international standards.
- Proficiency in quality control methods and tools such as SPC, FMEA, etc.
- Strong data analysis and problem-solving skills.
- **Personal Qualities**: Strong sense of responsibility, team leadership, good communication and coordination skills, and the ability to work under pressure.

Pay: RM6,000.00 - RM10,000.00 per month

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