Manager, Quality Assurance

TL;DR

Manager, Quality Assurance (Medical Devices): Oversee post-market complaints and document management to ensure procedural and regulatory compliance with an accent on ISO 13485, FDA 21 CFR 820, and EU MDD/MDR requirements. Focus on leading complaint investigations, managing regulatory body inquiries, and driving process improvements to improve compliance, accuracy, and efficiency.

Location: Manila, PH

Company

hirify.global is a digital healthcare company providing continuous cardiac monitoring and healthcare information services.

What you will do

• Supervise and lead Complaint Investigators and Document Management Specialists.
• Manage and balance team workload assignments to meet goals.
• Review investigated complaints to ensure procedural and regulatory compliance.
• Manage and respond to regulatory body inquiries related to reported complaints.
• Ensure documents are managed on time and complaints are closed within regulatory timeframes.
• Support Quality with data analysis and participate in process improvements for compliance and efficiency.

Requirements

• Bachelor’s Degree or Associate Degree in science, technology, or medical fields.
• 8+ years of Quality Assurance experience, preferably in complaint handling and/or post-market roles.
• 2+ years of experience as a Manager or Supervisor in a medical device company.
• Strong working knowledge of ISO 13485, FDA 21 CFR 820, and European Union MDD/MDR.
• Experience investigating and resolving complex issues with strong problem-solving and critical-thinking skills.
• Excellent verbal and written communication; strong technical writing and proficiency with MS Word, Excel, and Adobe Acrobat.

Culture & Benefits

• Fast-paced environment with cross-functional collaboration.
• Focus on improving patient outcomes and healthcare quality.
• Full-time role with an excellent benefits and salary package.

Hiring process

• Submit a resume including salary requirements to the provided application email.