LI
Specialist - Quality Assurance (Mid Level)
LanceSoft Inc
🇺🇸 United States
On-site
Mid level
3 weeks ago
$57 / hour
- triage
- CAPA
- GMP
- Technical Writing
3 weeks ago
Morning Shift (Mon to Fri)
What you’ll do
• Execute the triage, investigation, and closure of product quality complaints.
• Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.
• Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.
• Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.
• Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers
Who you are
• Bachelor’s degree required; additional training/education preferred through ASQ (or relevant society) and/or Master’s level program
• Minimum 3 to 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required
• Minimum 3 to 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
• Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance
• Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints
4 skills needed, Pharma background, quality Management Systems, Technical Writing and complete management experience
Specialist - Quality Assurance (Mid Level) · LanceSoft Inc