Quality Analyst (Medical Device) | Ortigas

Job Description:

• Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
• Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
• Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete
• Ensures issues are being addressed and escalated in a timely manner
• Maintains complaints log.
• Participates in process improvements.
• Perform other quality and regulatory-related duties as assigned.

Qualifications:

• Bachelor’s Degree or Associate Degree in science, technology, or medical fields
• 3- 5 years of experience in Quality Assurance and / or a complaint processing role.
• Previous experience in medical devices with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR is an asset
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues.
• Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions.
• Must work across functional teams within the organization and seek input from Product Quality, Product Development Engineers, and other departments for complaint investigation.
• Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions.
• Excellent communication (verbal and written) and interpersonal skills required.
• Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems.
• Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
• Must be able to work under minimum supervision and in a team environment.
• Must be a positive and energetic team player.
• Must be able to work at office for near future, shifting to hybrid once onboarding is complete.

Job Description:

• Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
• Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
• Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete
• Ensures issues are being addressed and escalated in a timely manner
• Maintains complaints log.
• Participates in process improvements.
• Perform other quality and regulatory-related duties as assigned.

Qualifications:

• Bachelor’s Degree or Associate Degree in science, technology, or medical fields
• 3- 5 years of experience in Quality Assurance and / or a complaint processing role.
• Previous experience in medical devices with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR is an asset
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues.
• Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions.
• Must work across functional teams within the organization and seek input from Product Quality, Product Development Engineers, and other departments for complaint investigation.
• Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions.
• Excellent communication (verbal and written) and interpersonal skills required.
• Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems.
• Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
• Must be able to work under minimum supervision and in a team environment.
• Must be a positive and energetic team player.
• Must be able to work at office for near future, shifting to hybrid once onboarding is complete.