Integrated Management System
Quality system regulatory compliance
- Execute quality related activities to ensure the quality system complies with relevant international and national standards and regulations, such as ISO 9001, ISO 13485, MDD 93/42/EEC, MDR 2017/745, 21 CFR Part 820, MDSAP and China GMP/GSP and etc.
- Assist the implementation of the current and updated regulation and standards within the organization Maintain and update all controlled files and records to ensure compliance with quality system requirements
- Collect data and generate reports of the quality system Key Performance Indicator and Management Review on regular basis.
Quality system standards implementation
- Localize global standards in a controlled time manner
- Assist the implementation of the local standards to fulfill the quality system requirement
- Maintain the master record of quality policy, quality procedures, working instructions, technical documents and other quality related records
Audit Management
- Support and perform the internal audit according to the audit program
- Support the external audit from Notified Body or Competent Authority
- Coordinate and assist in defining, implementing and following-up of systematic observations or corrective and preventive actions (CAPA)
Others
- Assist and support the quality system related software validation.
Product Quality
Field quality issue handling
- Collect and analyze Failure on Arrival (FOA), warranty claims and complaints which are
assigned to SDMI
- Coordinate the handling process with related internal stakeholders to ensure the customer
requirements such as replacement, repair, or further information can be fulfilled
- Work in cross-fuctional teams to take investigation and improvement actions for the quality
issues Track, review and close actions for individual quality issues
- Ensure the handling process complies with local regulatory requirements for any medical
device complaint or safety-related issue
Product quality issue handling
- Facilitate critical production quality issue handling with cross-functional team according to the internal KPI and external reported events
- Assist Product Quality leader to review Deviation Permit (DP) according to the current
processes and risk assessment system
- Assist Product Quality leader to initiate and complete Production Hold and Ship Hold
Quality review and improvement projects
- Participate in specific Product Quality Board (PQB) meeting, review product quality data with
the cross-functional team members, initiate and drive quality improvement projects (CAPA) during PQB meeting according to quality strategy and goal
- Align , support and validate the effectiveness of the certain CAPA to ensure the product CAPA
can be completed timely and effectively
- Discuss and decide related Technical Service Bulletin (TSB) activities in the Product Quality
Board (PQB) meeting
Post Market Surveillance
- Report Competent Authority (CA) and Technical Service Bulletin (TSB) to responsible authority
according to regulatory guidelines to fulfill the regulatory requirement
- Coodinate and communicate between legal manufacture and service technical support team in service department the announced Technical Service Bulletin (TSB) / advisory notice in Sales &Service organization
- Support manufacturer on the decision of reporting to CA by providing sufficient field failure
information
- Coordinate measures for announced safety-relevant quality problems to ensure the TSB implemented properly
- Determine measures and supervise their implementation, initiate and coordinate recall actions and other specific activities for TSB
- Gather and evaluate complaints about medical products of Drager from Greater China market
Coordinate, request, evaluate cause analysis and technical explanation from manufacturer
Provide related information to fulfill the query of internal and external customers
Review and close individual complaints
岗位要求
Position Requirements
-Bachelor's degree in science and technology or a comparable combination of education and experience.
-3-5 years of experience in quality system management.
-Knowledge of EC, EN, QSR and local target Market requirements- basic level
-Knowledge of FDA 21 CFR Part 820 - experienced level
-MDSAP - experienced level
-Knowledge of ISO 9001, ISO 13485, MDD and MDR- experienced level
-English in written and spoken - advanced level
-MS Office - advanced level
-Knowledge of quality improvement tools - basic level
-Knowledge of project management - basic level