Specialist, Quality Compliance

Edwards Lifesciences

Experience
Company Type
Workhours
Responsibilities

Key Responsibility:

1. Lead the investigation of complaints that include all complex scenarios:

o Evaluate event to determine if it qualifies as a complaint

o Manage customer relationship and expectations during course of complaint investigation and resolution process

o Assess complaint information provided and translate before submit to EU CHU

o Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations

o Prepare and submit MDR reports to NMPA, including China MDR and oversea MDR

o Translate and submit final customer correspondence

2. Analyze complaint and MDR data and report out by using monthly dashboard and quarterly PMS review meeting; Identify problems and escalate for any abnormal trending or hot issues. Lead and plan agenda for and run meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint.

3. Develop China PRAR plan and work with global stakeholder to prepare PRAR report with in accordance to regulatory requirements, trial safety processes, and EW procedures.

Complete PMS reports for Hongkong as per local regulatory requirements.

4. New Initiatives and projects

5. Other incidental duties

Education and Experience:

  • Bachelor's Degree or above in related field.
  • 3 years working experience in a medical device (cardiovascular, endovascular or other critical care/surgical products), healthcare or related environment.
  • Having clinical background.

Additional Skills:

  • Proven expertise in MS Office Suite and ability to operate general office machinery.
  • Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills.
  • Demonstrated problem-solving, critical thinking, and investigative skills.
  • Good ability to read, write and speak English and Chinese.
  • Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance.
  • Proficient knowledge of medical terms and human anatomy.
  • Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations.
  • Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing.
  • Ability to manage confidential information with discretion.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast paced environment.
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the department on projects.
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
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Confirmed 3 hours ago. Posted 30+ days ago.

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