Senior Quality

4 weeks ago

Hanoi, Vietnam Adecco Full time

**Responsibilities**:
**Integrated System Management (Quality, Occupational Health & Safety, Environmental System)**:

- Implement and maintain effective processes to meet IMS objectives, to provide evidence of compliance with relevant quality, occupational health, and safety and environmental (HSE) directives, standards, technical and legislative requirements.
- Establish, maintain, and monitor required fault signalling and improvement systems for quality, HSE systems consistent with the related global processes, including partnering with other functions: medical device incident reporting, complaint handling, corrective and preventive actions program, system for signalling unsafe situations, hazard identification and risk assessment system, incident, and accident registers.
- Analyse and report to management on the effectiveness and efficiency of IMS systems: corrective action program, vigilance and RAs, product recalls, advisory or warning notices, customer complaints, quality planning, internal/external audits, non-conforming products and incident and accident register.
- Implement and maintain effective controls for non-conforming product handling, reporting, labelling, and disposition, including partnering with other functions.
- Ensure implementation of field corrective actions and quality improvement projects (e.g., Failure-On-Arrival).

**Audit**
- Support, plan and organize external audits by notified bodies or customers in collaboration with Regional Quality Manager.
- Establish and maintain an appropriate local internal audit program, perform periodic inspections and internal audits in collaboration with Regional QRA Manager(s).
- Ensure elimination of findings from internal and external audits with appropriate immediate actions, root cause analysis, corrective actions, and effectiveness checks.

**Regulatory Affairs (RA) Management/ Product Registration**:

- Develop plans for ensuring timely registration of new/updated products.
- Identify and recommend options for engaging local RA partners to cope with changes to the regulatory framework.
- Supervise and monitor local RA partners supporting the company’s product registration needs.
- Participate in meetings with local competent authorities and local technical committees, anticipating trends in regulatory rules applicable to Company Business.
- Establish strong working relationships with the following parties.

**Experience requirements**:
**Experience**:

- Minimum 3 years of working experience.
- Experience with Regulatory Affairs.

**Skills**:

- Strong knowledge of the local regulatory framework.
- Knowledge of quality management systems.
- Communication skills.
- Strong influencing skills to lead executive management, peers, and subordinates.

**Education requirements**:
University degree or comparable business experience.

**Contact Person**:
Hoa Pham

Adecco

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