Highlights
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. • Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.
Numbers & Facts
| Location | Duncan, SC |
| Industry | Staffing/Employment Agencies |
| Salary | $57 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
06 months contract with possible extension.
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
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
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.