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Job Information

Philips Quality & Regulatory Associate in Seoul, South Korea

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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

  • Goal-focused/deadline-driven/results-oriented

  • 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

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