Assistant QA Manager

1 week ago

กรงเทพมหานคร, Thailand PRTR Full time

Our client provides manufacturing for Medical Devices Products.

**Key Accountabilities**:

- Being responsible for providing necessary training to employees for all QMS and GMP for Medical Devices.
- Controlling and maintaining document control systems in organizations such as Production Batch Records, Sterilization Reports, and all other controlled documents.
- Representing the Internal Audit Program and coordinating with QA & QC Manager to manage External Audit.
- Managing and controlling customer complaints including complete complaint reports as necessary.
- Managing product release - authority to release products including preparing Certification of Conformity and product certificate for customers.
- Reviewing our manufacturing specifications to identify materials needed for production.
- Researching, sourcing, and assessing the best vendors to supply the necessary materials.
- Visiting vendor facilities and observing the manufacturing environment to review and assess their procedures.
- Performing regular quality control audits to ensure vendors continue to comply with company and federal standards.
- Reviewing incoming supplies and products from vendors to check for defects and ensure quality.
- Conducting tests and assessments on products to identify quality issues.
- Maintaining detailed reports on supplier quality, including defect rates and areas that result in flaws.
- Providing technical advice and guidance to suppliers to reduce defect rates.
- Serving as a liaison between our company's senior management and the vendors to identify quality issues and come up with solutions.
- Being able to frequently travel locally and internationally, at times/occasionally on short notice.

**Qualifications**:

- Bachelors or above in Pharma/Medical Technology/Engineering.
- Minimum 3 years of relevant experience in QMS, and 3 years in Medical Devices/Pharma.
- Expert in MS office.
- Excellent written and verbal communication skills.
- Must have analytical ability and clarity of thought.
- Good team player.
- Leadership skills.

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