Medical Device Quality Analyst

2 weeks ago

Taguig, Philippines Ivoclar Vivadent Services & Support, Inc. Full time

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. #J-18808-Ljbffr

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