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Job: Quality Assurance Specialist, Cancer Diagnostics, Inc., Durham, NC

General Information


Job title:
Quality Assurance Specialist
Job location:
Durham, NC  27703 United States
Requisition code:
Date posted:
04/03/2019
Compensation:
• Starting Pay range (annual salary) $44,000-$47,000 (40 hours/week) plus benefits
Job category:
Quality Control
Quality Assurance
Employment type:
Full time

Job Description


Quality Assurance Specialist

• Cancer Diagnostics, Inc. (CDI), a well-established medical device manufacturing firm in the Raleigh-Durham area with approximately 30 employees has an immediate need for a full-time Quality Assurance Specialist.
• Starting Pay range (annual salary) $44,000-$47,000 (40 hours/week).
• Performance/salary review: Annual
• The QA Specialist initially will be a work/study position reporting to the Director of Manufacturing and Product Development. The person selected for this position will be mentored by a seasoned Quality Assurance Professional Consultant. After completing work-study training, the QA Specialist will be responsible for the Quality Management System administration and record keeping in accordance with regulatory requirements and ISO 13485 standards.

Founded in 1998, Cancer Diagnostics, Inc. (CDI) developed the first commercially available 7-dye color kit for marking tissue margins, CDI's Tissue Marking Dyes. Today, CDI offers one of the industry’s largest portfolios of anatomical pathology products to over 3,500 laboratories worldwide with shipping locations throughout the United States.

Our passion at CDI is improving the customer experience with better products and service. Among our goals are to produce and provide reliable products, easy ordering, on-time deliveries, overall value and guaranteed satisfaction.

Job Requirements


• Selection criteria:
• Minimum: Sufficient work/life experience to demonstrate a desire and ability to meet the requirements of the position, including at least six months experience at a facility with a quality management system conforming to a standard e.g. ISO 9000, 9001, 21001, 21101, 29001.
• Helpful:
o Work experience with a Medical Device firm,
o A basic understanding of 21 CFR, ISO 13485, and work experience in a firm regulated by the FDA.
• Minimum education required: College degree
• Helpful: Completion of one or more Quality Management System course including free FDA On-Line Course Modules available at CDRH Learn.
• A keen desire to study, learn and apply quality assurance, quality control, regulatory compliance principles, and regulatory requirements used in the medical device industry.
• Required skills: Microsoft Office proficiency, Communication - both written and oral, and above average attention to detail.
(Job number: 3831227)
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