Quality Director

3 weeks ago


Ho Chi Minh City, Vietnam Adecco Full time

Job LocationHo Chi Minh

Job typePermanent

Salary200,000,000-450,000,000 (VND)

Theo lĩnh vựcTop Management

ExperienceMore than 20 Năm

IndustryHealthcare

**Job summary**:
Adecco's client - a global pharmaceutical & medical device manufacturer is urgently looking for a highly esteemed Quality Director (open for expats) to join its strong team to realize the ambitious goals in Vietnam. The incumbent will be making a great impact on its operational improvement.

**Responsibilities**:

- The Quality Director will be a member of the site leadership team, and a successful hands-on contributor to the manufacturing site. This individual will build and lead a quality and execution team to deliver its operations growth plan. The Quality Director will foster an environment that encourages Core Values, innovation, and continuous improvement.
- Quality Management System (QMS): Establish and oversee the development of a robust QMS that aligns with industry standards (e.g., ISO 13485) and regulatory requirements (e.g., FDA, CE Marking).
- Regulatory Compliance: Ensure that all quality processes and products meet or exceed relevant regulatory requirements and standards, including but not limited to FDA, ISO, and other global regulatory bodies.
- Quality Strategy: Collaborate with the VP, Quality to define the quality strategy for the organization and set clear objectives and key performance indicators (KPIs).
- Cross-Functional Collaboration: Work closely with engineering, manufacturing, and other internal and external teams to integrate quality considerations into product development, manufacturing, and supply chain processes.
- Supplier Quality Management: Develop and implement supplier quality management processes to ensure the quality of components and materials used in our medical devices.
- Risk Management: Lead risk management activities to identify, assess, and mitigate quality-related risks across the product lifecycle.
- Audits and Inspections: Prepare for and manage external audits and inspections by regulatory agencies and notified bodies.
- Continuous Improvement: Drive a culture of continuous improvement, implementing best practices and driving efficiency in quality processes.
- Team Leadership: Build and mentor a high-performing quality team, fostering a culture of accountability and excellence.
- Establish and lead the Change Management process
- CAPA - Corrective and Preventative Actions system
- Help setup Quality Control Operations for some Incoming Inspections
- Define and implement finished product release process
- Support HHE (Health and Hazard Evaluations), Recalls, FAA (Field Action Planning)
- Present to Management Review on Metrics (NCMRs, CAPAs, Supplier Quality, Audits, etc.)
- Support Customer Communication Processes establishment
- Support Supplier Audits and Supplier Monitoring

**Experience requirements**:

- Over 10 years of progressive quality management experience in the pharmaceuticals or medical device manufacturing.
- Experience leading and developing teams.
- In-depth knowledge of FDA regulations, ISO 13485, and other global quality standards.
- Proven track record of successfully implementing and managing quality management systems.
- Experience working with external manufacturing partners is a plus.
- Strong leadership, communication, and interpersonal skills.
- Excellent problem-solving and decision-making abilities.
- Able to lead within ambiguity and pivot quickly as priorities change within a rapidly growing startup environment.

**Education requirements**:

- Bachelor's degree in Engineering or related majors

**Contact Person**:
Hai Nguyen

Adecco


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