The Role
The Quality Engineer ensures compliance of materials and processes, conducts investigations, trains staff, and engages in continual improvement initiatives.
Summary Generated by Built In
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:
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.
- Bachelor’s degree in engineering, material sciences, chemistry, biology or other related fields.
- 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.
Top Skills
Acumatica
Elemental Analyzer
Keyence Microscope
MS Office
Qualio
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The Company
What We Do
At Carolina Components Group, our commitment to quality and customer service is unsurpassed. Backed by a full range of products such as stainless steel tube & fittings, diaphragm valves and process hoses, we are able to provide fluid handling solutions when you need them.
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