Title: Quality Engineer

Job Type: Full time

Location: Durham, NC 27703

Summary: The Quality Engineer is responsible for ensuring that all materials and processes utilized for single use assemblies, process hoses, and value-added resale/distribution orders comply with relevant CCG, customer, and regulatory requirements. This individual will be responsible for collaborating with cross functional teams to ensure compliance of products, conduct investigations, engage in continual improvement activities, training staff on technical topics, and complete data analysis and reporting.

Essential Duties and Responsibilities:

Responsible for operating and maintaining a Keyence microscope and elemental analyzer
Responsible for processing investigation and product requests for analysis using the Keyence system
Responsible for establishing and perpetuating a materials compliance system incorporating particulate and material profiles
Responsible for being informed about relevant regulations (i.e. FDA, GMP, EU regulations) concerning materials used in CCG products for industry application
Responsible for ensuring documented information pertaining to materials is captured, maintained, and kept up to date with supporting documentation
Responsible for operating as a subject matter expert for elemental analysis of products/materials and product analysis
Works collaboratively with CCG team members, customers, and suppliers for overall material compliance management
Responsible for supporting investigations relevant to materials and how those materials may be impacted and/or impact other materials
Responsible for supporting material questionnaires, data requests, product specification documentation, etc. as related to materials and CCG compliance
Responsible for compiling the necessary documentation to enroll products internally to CCG, CCG suppliers, & CCG customers
Conducts testing, validation, and review activities as required for materials and processes relating to the QMS
Responsible for training CCG team members within technical scope of knowledge
Responsible for conducting CCG process, equipment, and metric data analysis activities and reporting
Responsible for engaging and driving continual improvement initiatives related to product/material analysis
Ability to draft, author, review, and approve formal documentation such as standard operating procedures, work instructions, Installation Qualifications, Operational Qualifications, Performance Qualifications, Engineering Reports, Protocols, etc
Responsible for performing standard quality functions relating to CAPAs, nonconforming events, investigations, customer complaints, etc
Additional tasks may be required at the discretion of CCG Management

Desired Education:

Bachelor’s degree in engineering, material sciences, chemistry, biology or other related fields

Desired Skills & Experience:

2-4 Years Experience with Microscopy and/or spectroscopy
2-4 Years Pharmaceutical/Biotech Manufacturing experience
Strong skillset with regulatory standards and compliance as related to bioprocessing, pharmaceutical process, and other related applications
ERP experience (Acumatica)
Electronic Quality Management System (eQMS) experience (Qualio)
Strong computer skills including Microsoft Office
Strong Organizational skills
Effective communication skills
Strong Individual ability to manage time, projects, and tasks

Carolina Components Group, Inc

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