QA Specialist

<h2>Job Overview:</h2><p style="margin: 0in 0in 0pt 0.25in;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Covance by Labcorp is currently hiring for a<em> <strong>Quality Assusrance</strong></em></span><span style="font-family: Arial, sans-serif; font-size: 10pt;"><em><strong> Engineer</strong></em> to join our growing team in <strong>Morrisville, North Carolina</strong>.  The Quality Specialist is responsible, under Director level supervision, for leading, supporting and ensuring continued suitability of the Quality Management System (QMS).</span></p><p style="margin: 0in 0in 0pt 0.25in;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">*</span><strong><span style="font-family: Arial, sans-serif; font-size: 10pt;">Relocation Assistance available* </span></strong></p><p style="margin: 0in 0in 0pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;"> </span></p><h1 style="margin: 0in 0in 0pt 0.25in;"><span style="font-size: 10pt;"><strong><span style="color: windowtext; font-family: Arial, sans-serif;">Essential Duties and Responsibilities</span></strong></span></h1><ul><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Ensure that the Quality System is compliant with domestic and international quality system regulations (21 CFR 820; ISO 13485).</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Promote awareness of the Quality System and provide training to individuals across the organization on quality management principles, tools, techniques and best practices. </span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Support the implementation of corporate policies and procedures relating to quality, design control, risk management, project management, process development, supplier management and FDA/ISO compliance.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Engineer solutions to address product and process quality issues.   Work as part of a team to drive forward continual improvement initiatives and address compliance challenges.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Support the research, development and manufacturing of in-vitro diagnostic (IVD) medical device products. Lead the planning, design, preparation, execution, reporting, and analysis of design verification and validation efforts to qualify materials, tools, equipment, systems, processes, and software used in the testing, processing, manufacturing, storing, and distribution of IVD products.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Initiate and coordinate the inspection and testing of raw materials, work-in-process, finished goods and environmental conditions.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Design and develop forms, instructions and sampling procedures for recording, evaluating, and reporting quality and reliability data. </span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Manage and maintain design history files, risk management files and device history records to ensure design and development activities are executed as required.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Coordinate and support the Corrective / Preventive Action (CAPA), Change Control and NCM/MRB systems.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Support the document control and training system.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Lead the investigation, reporting, and resolution of customer complaints. </span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Conduct supplier audits and partner with suppliers to address Requests for Supplier Corrective Action (RSCA).</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Coordinate and support the annual audit program; manage, schedule, perform and report on internal, external and supplier audit activity. </span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">Compile and report quality metrics. Assess and report post-market surveillance data in accordance with regulatory requirements.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="color: #000000;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Bachelor’s Degree in Biology, Chemistry, Life Sciences or Engineering required, Master’s Degree preferred.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">At least 3 years of experience in a quality working with ISO 13485</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Note: An advanced degree in Biology, Chemistry or Life Sciences accepted in lieu of professional experience.</span></li><li><span style="font-family: Arial, sans-serif; font-size: 10pt;">ASQ Certified Quality Engineer and Six Sigma Black Belt preferred.</span></li></ul><h2>Experience:</h2><ul><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Thorough understanding of quality philosophies, principles, systems, methods, tools and standards</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;"> Through understanding of customer expectations, supplier relations and continual improvement practices</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Experienced in acquiring and analyzing process data using appropriate quantitative and statistical methods across a spectrum of business environments to facilitate process improvement</span></li><li style="color: #000000;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Excellent communication skills</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Excellent writing skills</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Strong organizational skills</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Ability to handle multiple projects simultaneously</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"><span style="font-family: Arial, sans-serif; font-size: 10pt;">Exhibits self-reliance in managing personal workload and schedule of deliverables</span></li></ul>