Category

Description

• Receive and initiate product complaint investigations using product complaints management software.
• Apply departmental procedures to asses product complaints’ impact on patient safety and product quality compliance.
• Notify the Complaint Manager regarding product complaints with potential regulatory notification.
• Interface and collaborate with various departments, including Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance and vendors and contractors on product complaint issues.
• Conduct follow-up with reporters for additional information necessary to complete a detailed investigation. Provide responses to product complaint reporters.
• Support product complaint investigations.
• Data entry and analysis to support tracking and trending of complaints.
• Data entry and analysis to support electronic Quality Management System.
• Perform other duties as assigned.

• Bachelor’s degree in engineering or life science.
• 0-3 years of experience in Quality Assurance or a GMP-related field within the medical device or pharmaceutical industry.
• Exceptional attention to detail and good organizational skills.
• Excellent communication skills.
• Skilled in technical writing.
• Ability to work independently and able to schedule work with limited supervision to meet deadlines.
• Ability to develop solid working relationships with colleagues, partners, and contractors.

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