Medical Device Quality Analyst

4 hours ago

Bonifacio Global Metro Manila, Philippines Ivoclar Vivadent Services & Support, Inc. Full time ₱1,200,000 - ₱2,400,000 per year

We are seeking a detail-oriented and analytical Quality Data Analyst to join our team. This role is critical in ensuring the safety, performance, and regulatory compliance of medical devices in the market, with a strong focus on the EU Medical Device Regulation (MDR).

What You'll Do:

  • Collect and analyze data related to the quality, performance, and safety of medical devices post-market, ensuring alignment with global regulations, especially EU MDR.
  • Create Complaint and Corrective and Preventive Action (CAPA) Analysis Reports based on complaint data.
  • Evaluate incoming data to ensure it meets defined parameters and organize it into comprehensive reports.
  • Assess data for undesired product effects, reportable incidents, trend identification, Field Safety Corrective Action (FSCA) initiation, and updates to Risk Assessments.
  • Conduct global complaint reviews to identify patterns and ensure regulatory compliance.
  • Perform medical assessments of complaints to support high-level Post-Market Surveillance reporting.

What We're Looking For:

  • Bachelor's degree in a relevant field (e.g., Biomedical Engineering, Life Sciences, Nursing, Pharmacy).
  • Experience in post-market surveillance, complaint handling, or regulatory affairs within the medical device industry.
  • Strong understanding of EU MDR and global medical device regulations.
  • Excellent analytical, reporting, and communication skills.
  • Ability to work independently and collaboratively in a cross-functional environment.

What We Provide:

· TRAINING: You will work with various members of our team locally and onshore to ensure you are set up for success.

· SUPPORT: A close-knit coaching and mentoring system to help you ease into the company and into your role with confidence.

· COMP & BEN: Ivoclar believes in compensating employees fairly for their skills and experience and has designed the total rewards package for long-term relationships.

· TOOLS: Everything you need to help you do your work will be provided.

· WORKING ENVIRONMENT: Ivoclar prides itself on being a family-owned company with strong values so everyone we bring in becomes part of that global family.

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