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Regional QA Director, Medical Devices

Job Title: Regional QA Director, Medical Devices
Contract Type: Permanent
Location: Singapore, Singapore
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: SH18415_1549877071
Contact Name: Phua Shyan-Hwei
Contact Email: Sphua@profileasia.com
Job Published: February 11, 2019 17:24

Job Description

Regional QA Director, Medical Devices

This is a newly created role with a global medical device organisation, reporting to the Vice President of Quality. As a member of the APAC leadership team, you will serve as a strategic partner to the organisation, customers and internal project teams to drive product quality, ensuring that projects and deliverables are compliant with regulatory requirements and industry best practices.

Some of your key responsibilities include

  • Quality and GMP compliance oversight for commercial quality, R&D, field services and manufacturing facilities
  • Lead the Regional Quality Management Review and interface with senior management to discuss quality and compliance issues and supports the management and resolution to quality issues
  • Facilitate proactive quality through identification and management of risks and implementation of CI activities
  • Provides actionable insights from quality and operational data analysis and working with country teams to address post-market surveillance obligations and CI
  • Facilitate development of CAPA plans
  • Drive inspection readiness activities
  • Host and support site audits
  • Contribute to the development of global risk-based internal audit plan

Degree qualified, you will have at least 10-15 years of QA experience, with regional exposure in APAC markets, ideally in clinical quality in a medical device, biotech or pharma sector. You must be able to develop and work within quality systems compliance with FDA QSR and ISO 13485 and demonstrated experience in leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility. You have practical experience applying proactive quality approaches for R&D, product development and clinical trials. A proven leader with excellent team building and communication skills, you are able to work constructively and effectively at all levels and with external customers. Limited travel (20%) and night calls are required as part of the job responsibilities.

Singapore Employment Agency Licence No: 16S8069

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