Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
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Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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