Gentuity, LLC
Quality Engineer - Post Market Surveillance (Sudbury)
Gentuity, LLC, Sudbury, Massachusetts, United States, 01776
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
Manage Gentuitys complaint handling process ensuring compliance with regulatory standards and Gentuitys 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 Gentuitys internal and external customers. Train team members in complaint management best practices. Maintain accurate documentation of all complaint-related activities in Gentuitys 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:
Time management skills Microsoft Word, PowerPoint, Excel experience Organization skills 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:
Bachelors 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.
Manage Gentuitys complaint handling process ensuring compliance with regulatory standards and Gentuitys 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 Gentuitys internal and external customers. Train team members in complaint management best practices. Maintain accurate documentation of all complaint-related activities in Gentuitys 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:
Time management skills Microsoft Word, PowerPoint, Excel experience Organization skills 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:
Bachelors 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.