by Joey Chen in Healthcare
8th Mar, 2021
Quality Specialist-Medical Devices
Our client is looking for a Quality Specialist for Medical Devices in Guangzhou
- Set up supplier and product qualification standards and supplier management programs on HSS(Hygiene Safety and Sanitation) category.
- Deploy the standards and quality management programs to HSS suppliers.
- Responsible for HSS supplier qualifications (including plant audits/visits), product functional evaluation and qualification on quality and follow up with suppliers on improvements where necessary and provide qualification reports to market applicator.
- Responsible for HSS supplier quality management and lead on improvement initiatives, manage supplier changes and assure suppliers deliver consistent quality of HSS products to the market.
- Quality & compliance data collection (e.g. 3rd party audit reports, test reports, certificates, etc.) and keep them update to date.
- Complaint management including data management; complaint sample validation, root causes analysis with suppliers and monitor the progress; follow-up with suppliers on corrective actions, and report to the market.
- Set up and optimize the HSS technical specifications and data sheets with the markets as required. Integrate “voice of customer” and market regulatory requirements into the HSS specifications with the support from compliance team.
- Work closely with suppliers and the company Compliance and Safety team to monitor and manage supplier quality & compliance performance and drive continuous improvement. Provide supplier quality performance data to Sourcing to understand supplier’s capabilities.
- College graduate or above with at least 5 years’ experience in a quality role in the manufacturing of an HSS category, especially masks.
- Preferred candidates will have experience in chemical or medical apparatus and instruments, with knowledge of the health, safety and hygiene industry with technical experience.
- Working knowledge of ISO 13485, BRCGC/cp, ISO9001 management systems, with strong technical knowledge of HSS products (mask, glove, sanitizer, thermometer, etc.). Must have expertise in the mask manufacturing industry.
- Good English communication skills, excellent organizational skills.
Please send me your updated CV with expected salary to firstname.lastname@example.org if you are interested in this job.