Quality Assurance Specialist
Pittsburgh Metro Area, PA
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. Process the download and distribution of Complaints daily. Identify those Complaints requiring escalation. Work with customer service to fully document the customer's allegation and facilitate the return of product to be evaluated. Coordinate investigations with suppliers, and communicate root cause and corrective actions to customers. Coordinate investigation of quality issues with customers and suppliers. Review, approve and communicate root cause and corrective action to stakeholders. Facilitate the quarantine, recovery and disposition of products including those that may be sensitive in nature for regulatory or legal reasons. Collect and analyze quality data, run Oracle queries, and prepare and distribute quality reports. Respond to customer surveys and Requests for Proposal, (RFPs) in a timely manner. Create and revise QA procedures and work instructions. Participate in internal audits of the Quality Management System. Participate in continuous improvement of core processes, using Practical Process Improvement (PPI). Present QA functions and provide training as required to departments outside of QA. Execute projects and complete other duties as assigned.
Organized and works with a sense of urgency. Attention to detail. Ability to multi-task. Customer focused. Flexible team player. Excellent oral and written communication skills. Experienced in dealing with customers and suppliers. Skilled problem solver with a results orientation. Strong computer and analytical skills, including: data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, and Data Warehouse tools. Experienced in a continuous improvement methodology and related analytical 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. Experienced internal or external auditor, lead auditor experience preferred. Experience working with a quality information management system, Master Control preferred
Bachelor's Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics. Ability to travel and work in a laboratory, warehouse or manufacturing environment; less than 15% of the time.
Non-Negotiable Hiring Criteria: (List 3-5 key skills or position requirements that the candidate must have to be considered for this position.) Experience in dealing with customers and suppliers. Skilled at root cause analysis and problem solving with a results orientation. 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