In this role, you have the opportunity to
Manage Quality Management System according to OneQMS
Manage consumer complaints and adverse event
Maintain quality metrics and report KPIs to stakeholders
You are responsible for
Ensures suitable responses to audit non-conformances are provided by auditees within agreed upon timeframe.
Provides support ensuring external audit readiness and during external audits
Ensure overseeing quality control procedures in 3PL including incoming inspection, nonconformance management and traceability.
Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed.
Responsible for the controls and quality standards of Quality Management System including Corrective/Preventive Action, Non-Conformances and Change Control, Document Control, GMP/GDP training management, Quality agreements.
Ensures document control is established and ensures training profiles are assigned and enforced and training administration.
Ensures the monitoring on annual training plan and execution and makes sure that adequate training is carried out to new employees.
Establish, monitor and respond to metrics on the efficacy and efficiency of the Training Administration and Control activities and its ability to support the business.
Monitor the quality performance and report KPI results periodically to stakeholders.
Timely Report Voluntary Recalls, Incident Reports and Adverse Events as well as gov’t monitoring responses on overseas safety related reports
Ensures communication with the Business Units and internal stakeholders with regard to adverse events reporting.
Monitors and analyses FSCA activities, including reporting to the local competent authorities
Evaluates customer feedback, service records, and other sources of customer and internal for possible complaint.
Responsible to assess possible adverse event and communicate with both BG and local Regulatory Affair to comply with regulatory requirements
To succeed in this role, you should have the following skills and experience
Bachelor’s degrees or above
More than 5 years QA experience in Medical Devices and/or Pharmaceuticals
Good knowledge of cGMPs, GDP, Standard procedures, ISO 9001 and ISO 13485 related to Medical Devices and/or Pharmaceuticals
Good knowledge of Quality Management system and local regulations related to Medical devices
Good knowledge competency on Quality System including CAPA, Quality Inspection, consumer complaint handling and audit readiness
Experience of MFDS, internal audit and follow-up actions report is preferred
Strong listening, written, and verbal communication skills
Strong time management, prioritization, and organization skills
Proficient in Microsoft Word, Excel and PowerPoint, CRM knowledgeable
Fluent in English, verbal and written in addition to local language