Gentuity, LLC
Quality Engineer - Post Market Surveillance
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: Manage Gentuity’s complaint handling process ensuring compliance with regulatory standards and Gentuity’s QMS. Analyze and categorize complaints to develop metrics and identify trends and areas for improvement. Collaborate with cross‑functional teams to promptly investigate and resolve complaints. Prepare and submit detailed reports on complaint investigations to Gentuity’s internal and external customers. Train team members in complaint management best practices. Maintain accurate documentation of all complaint‑related activities in Gentuity’s eQMS system. Supporting members of CAPA team aiding in investigation and root cause analysis. Provide support for test method development used to determine robust complaint and CAPA root cause. Support any Post Market Surveillance activities as required to maintain compliance per regulatory requirements. Other duties as assigned EXPERIENCE/SKILL REQUIREMENTS: Microsoft Word, PowerPoint, Excel experience 1 – 3 years, experience in a medical device or pharmaceutical environment. Investigation experience related to product performance. Previous experience with eQMS systems preferred. EDUCATIONAL REQUIREMENTS: Bachelor’s Degree, in a Technical or Scientific / Engineering discipline preferred, OR an equivalent combination of Education and Work Experience. Equivalence work experience, a minimum of 5 years work experience in medical device or pharmaceutical industry. Seniority level:
Associate Employment type:
Full‑time Job function:
Quality Assurance Industries:
Medical Equipment Manufacturing
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SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: Manage Gentuity’s complaint handling process ensuring compliance with regulatory standards and Gentuity’s QMS. Analyze and categorize complaints to develop metrics and identify trends and areas for improvement. Collaborate with cross‑functional teams to promptly investigate and resolve complaints. Prepare and submit detailed reports on complaint investigations to Gentuity’s internal and external customers. Train team members in complaint management best practices. Maintain accurate documentation of all complaint‑related activities in Gentuity’s eQMS system. Supporting members of CAPA team aiding in investigation and root cause analysis. Provide support for test method development used to determine robust complaint and CAPA root cause. Support any Post Market Surveillance activities as required to maintain compliance per regulatory requirements. Other duties as assigned EXPERIENCE/SKILL REQUIREMENTS: Microsoft Word, PowerPoint, Excel experience 1 – 3 years, experience in a medical device or pharmaceutical environment. Investigation experience related to product performance. Previous experience with eQMS systems preferred. EDUCATIONAL REQUIREMENTS: Bachelor’s Degree, in a Technical or Scientific / Engineering discipline preferred, OR an equivalent combination of Education and Work Experience. Equivalence work experience, a minimum of 5 years work experience in medical device or pharmaceutical industry. Seniority level:
Associate Employment type:
Full‑time Job function:
Quality Assurance Industries:
Medical Equipment Manufacturing
#J-18808-Ljbffr