Quality Engineer - Post Market Surveillance
Gentuity, LLCSudbury, MA, United Statesjob_description.job_card.variable_hours_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionTime 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. 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.
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 :
EDUCATIONAL REQUIREMENTS :
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Quality Engineer • Sudbury, MA, United States