Quality Assurance Service Investigation Manager

Reports To: Director of Quality Assurance (QA) Devices

Summary:

This position is responsible for overseeing customer complaint and service investigations within the Quality Assurance department. The primary function is to ensure all complaint and service records are complete, accurate, and meet regulatory requirements.

Responsibilities:

• Investigate customer complaints and service events by collaborating with internal teams and subject matter experts.
• Ensure complaint and service investigation records comply with relevant regulations (FDA, EU) and company procedures.
• Conduct detailed investigations of adverse events, analyzing device data to determine potential relationships.
• Manage timelines and ensure investigations are completed efficiently and effectively.
• Support risk assessments and escalated investigations through complaint review and contributing to risk committee decisions.
• Manage service-related change controls, corrective action plans (CAPAs), and collaborate with the Contract Manufacturing Organization (CMO) on complaint investigations.
• Provide analysis to design, engineering, and manufacturing teams regarding the effectiveness of implemented solutions based on complaint and service trends.
• Document complaint and service investigations within the electronic Quality Management System (eQMS).
• Collaborate with service teams to define service call or customer complaint categorization.
• Conduct periodic reviews of service quality system activities.
• Review and approve Returned Goods Evaluation (RMA) records.

Qualifications:

• Bachelor’s degree in engineering or a related field.
• Minimum 4-5 years of experience in the medical field with complaint handling and/or customer service.
• Experience reviewing medical/health records and providing analysis.
• Prior experience in regulatory compliance and/or quality assurance is a plus.
• Working knowledge of relevant regulatory requirements, including:
  • FDA 21 CFR 820 and 803 regulations
  • ISO 13485 (minimum)
  • Familiarity with 21 CFR Part 4 and EU MDR (preferred)
• Proficient in Microsoft Office Suite.
• Fluent in Hebrew and English (written and spoken).

Additional Notes:

• Self-motivated with a strong desire to succeed.
• Excellent technical understanding.
• Flexible and able to meet deadlines.
• Strong organizational and planning skills.
• Ability to multitask and manage multiple projects.
• Excellent attention to detail.
• Effective interpersonal, written, oral, and presentation skills.
• Ability to work independently and as part of a team.