Quality Assurance Manager, PDx Asia

GE HealthCare

  • 上海市
  • 长期
  • 全职
  • 7天前
Job Description Summary The QA Manager is responsible for ensuring GE Healthcare PDx’s regional quality and regulatory compliance across Asia, including China, Hong Kong, Taiwan, Korea, Japan, and all associated wholesalers and distributors. This role focuses on maintaining high standards of product quality and regulatory adherence while driving process efficiency and effectiveness.
The QA Manager serves as the primary quality representative to external agencies and partners, and plays a key role in fostering and advancing a strong quality culture throughout the region.GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.texJob DescriptionKey responsibilities include:
  • Directing the Site Quality Management System, fully integrated into the GE Global Quality Management System, including cross-functional, 3rd party partners and country-specific processes.
  • The role is the responsible for regional compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization in the region.
  • Maintaining and improving all aspects of Quality Planning.
  • Overseeing all Quality-related communications and training requirements for all employees.
  • Establishing positive relationships with outside agencies.
  • Ensuring audit & inspection readiness of all sites in the region.
  • Overseeing the Deviations/Investigations, Corrective Action / Preventive Action activities and Complaint Handling Programs.
  • Report on Quality System effectiveness and requirements to management team as required including compliance of 3rd party GDP partners in the region.
  • Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.
  • Accountable for each of the metrics for the business (i.e. complaint, internal audit score, employee engagement, etc.) and management review process
  • Participating in selected global initiatives to share best practices and leverage quality synergies.
  • Acting as Management Representative for Quality at the Region.
Quality Specific Goals:Aware of and comply with the GEHC Quality Manual, Good Distribution Practices, Pharmacovigilance (PV), Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. Complete all planned Quality & Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required. Maintain full Quality System Regulations and Current Good Manufacturing Practices Requirements ensuring compliance to regulations and legal requirements through successful and effective quality management systems. Identify and ensure timely closure of corrective and preventive actions for the site. Participate and represent the Site in external Audits. Mentor and coach direct reports to successful understanding and implementation of Quality System Requirements. Timely communication of all quality concerns, initiatives, and information to the site Management team. Meet specific quality metrics and/or milestones as defined in annual business objectives. Operates a Local Inspection program and manages follow up activities to close Nonconformities.Qualifications:Bachelor's degree in Scientific Field (e.g. pharmaceutical, chemical engineer, chemistry, bio-medical science, food science and other relevant fields) Understanding of product development, manufacturing, quality control and servicing in a medical equipment environment. Minimum 5 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry. Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities. Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements. Proven track record in performing external and internal audits. Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations. Effective report, business correspondence and procedure writing skills. Good problem identification, multivariable analysis and creative resolution aptitude. Proven process development and project management skills. Strong computer skills. Ability to communicate using EnglishPreferred Qualifications:Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions. Experience in a global, matrixed organization structure. Professional certification as a GDP or PV Lead Auditor. Six Sigma training and/or certification Team player with a global mindset. Strong Change Acceleration skills. Experience in building a Quality System from ground up.Inclusion and DiversityGE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

GE HealthCare