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Quality Assurance Specialist
Ref No.: 18-26113
Location: Allentown, Pennsylvania
Position Summary:
Work directly with customers and suppliers to quickly address quality related issues. Responsible for the day to day execution of core quality processes under the supervision of Director, Quality Assurance with mentoring from more senior QA Specialists (Skill levels II and III). Key Responsibilities: Participate in all aspects of the QA job function, e.g. processing of Complaints, Quarantine, Recovery, Customer Recovery and Advisories (QRRs), change notifications, customer surveys, quality certificates, internal audits, SalesLogix tickets, generation of supplier and team metrics, etc.

Experienced in a continuous improvement methodology and related analysis tools, e.g. Six Sigma, PPI, Lean, Minitab, Corrective and Preventive Action (CAPA), run charts, flow charting, Pareto charts, pivot tables etc. Minimum two years' experience working in an ISO (13485 preferred) and/or FDA current Good Manufacturing Practices (cGMP) environment. Bachelor's Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics. This position has not been approved for Relocation Assistance