Work Schedule

Environmental Conditions

Job Description

COMPANY:                            Thermo Fisher Scientific, Inc.

LOCATION:                            6086 W. Ten Rd., Mebane, NC 27302

TITLE:                                    Engineer III, QA

HOURS:                                  Monday to Friday, 8:00 am to 5:00 pm

DUTIES:                                 Execute planned and systematic activities implemented in a quality system, so quality requirements for products, processes, systems, or equipment will be fulfilled for the site supply chain.

                                                Ensure company goals and objectives, policies, and procedures are in compliance with the Quality Systems and FDA regulations.

                                                Ensure quality systems SOP’s are being followed and alert Quality team in any discrepancies found to drive escalation and corrective actions.

                                                Trend and assess data to track program effectiveness and identify areas of risk.

                                                Perform statistical analysis to analyze trends, work with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and contribute to and track data to support at the site level (e.g., yield improvements, CAPA, compliant, and scrap reduction).

                                                Lead teams to conduct root cause analysis.

REQUIREMENTS:                  Master’s degree or foreign degree equivalent in Biomedical Engineering, Biology, Chemistry, or related field of study plus 2 years of experience as a Quality Engineer, or related occupation. Employer will also accept a Bachelor’s degree or foreign degree equivalent in Biomedical Engineering, Biology, Chemistry, or related field of study plus 4 years of experience as a Quality Engineer, or related occupation as an equivalent alternative.

                                                Required knowledge or experience with:

                                                FDA 820;

                                                ISO 13485;

                                                Trackwise, SAP, Minitab, or Salesforce;

                                                Supplier Quality Engineering to issue and manage supplier SCARs;

                                                FDA inspections;

                                                ISO 9001 and Corporate Audits;

                                                Metrics and Reports;

                                                Excel.

#LI-DNI

87433737.v1-IMMIGRATION