PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Accountable for ComOps Quality objectives, you lead programs for developing, implementing and continually improving systems to ensure customer requirements are implemented into company products and services provided.
- Serve as the Quality Management Representative for China;
- Overall supervision of quality management system in ComOps and other collaborative project;
- Ensure the deployment of the Quality Policy and Objectives and the effectiveness of the Quality Management System;
- Ensure the conformity of the Quality System of the company towards regulatory requirements, including ISO9001， ISO 13485, Medical Device and IVD Regulation in China
- Develop and implement Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives;
- Ensure that written procedures are maintained to define the specifications and procedural requirements affecting product quality, and that effective change controls are maintained to assure that any changes are thoroughly reviewed and shown to be appropriate, including review for their potential to affect validations or regulatory submissions;
- Assist and develop the implementation of Corrective and Preventive Action programs including necessary procedures, records, and trend reports. These programs lead to process and product improvements;
- Establish, maintain and improve reports of quality data to assist the continuous improvement of quality and analyze them to assess the effectiveness of the company quality system. This data is included in regular reports to General Manager for the Quality System Management Reviews;
- Report on the functioning of the Quality System to the General Manager as responsible for conformity with the requirements of the Quality Management System; Ensure that organization and Quality Control procedures to perform the testing of raw materials, components, semi-finished and finished products, are relevant, validated and in compliance with the customers’ expectations and regulatory requirements; Responsible for the batch release management; Monitor validation master plan.
- As the primary contact of the local regulatory authority (NMPA) , the certification body (GMED and DNV) and the Quality Assurance organization of BioMérieux SA and bioMerieux Shanghai;
- Oversee post market surveillance activities including customer complaints handling resolution, field action, adverse event reporting.
- Ensure implementation and compliance of processes of Distributor management, Supplier management, and Labeling from QA perspective.
- Managing the staff of Quality department; Leads or facilitates teams to accomplish the deliverables, milestones, and objectives meeting the plans and schedules ensuring that any changes to the plans are communicated and agreed to by the teams and project sponsors.
- Communicates progress of the quality objectives to all levels of the organization.
KNOWLEDGE, LANGUAGE AND EXPERIENCE
- Bachelor’s Degree with > 5 years of industry experience or equivalent experience in related industry.
- > 3 years team managerial experience.
2. Skills and Qualifications:
- Good leadership and communication skills.
- Experience in participation in the management of regulatory audits (i.e. ISO 9001, ISO 13485, ANSM, FDA, NMPA, etc.).
- Knowledgeable in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, etc.).
- Fluent Chinese required; Good command of English in both written and oral