Sun. Feb 16th, 2025

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If you are looking for a Engineering Job ? Then, This is the place where you can find All sources of Job opportunities with detailed information.

Job Category : Engineer
Company Name: StimLabs
Position Name: Validation Engineer
Location : Roswell, GA 30076
Job Description : KEY DUTIES AND RESPONSIBILITIES
Leads and performs software, equipment, and process validations with guidance/support from Quality Engineering Management
Performs Quality review of software, equipment, and process validations
Operates under the supervision of Quality Management
Leads or participates in corporate or quality projects for continuous improvement and to identify potential quality issues
Identify opportunities for Quality within software processes, e.g., ability to identify Quality Management System (QMS) needs
Maintains validation state of control in collaboration with quality
Contributes to the infrastructure for new products
Setting up quality controls for engineering roles and responsibilities for equipment and processes
Perform statistical analysis and design experiments to support processing development, process control, and process improvement
Designs models and drawings using applicable CAD programs. Also, reviews junior level engineers’ drawings for accuracy
Collect, analyze data and prepare key performance reports to management
Cross-functional collaboration with Operations, R&D, and IT
Performs root cause analysis efforts for CAPA, Nonconforming Product, Deviations, and Investigations
Supports calibration and preventative maintenance programs for production equipment, test equipment, analytical equipment, and the facility
Develops and sustains Risk Management files while maintaining governing regulations, standards and internal compliance

EDUCATION/CERTIFICATION
Bachelor’s degree in a technical/relevant field, with at least five (5) years of Quality Assurance and related Software experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience
REQUIRED KNOWLEDGE and EXPERIENCE
Knowledge and understanding of regulatory requirements, including but not limited to 21 CFR 1271, AATB, ISO 13485, cGTP, cGMP, 21 CFR 820, 21 CFR 210 & 211, and other applicable state and federal regulations
Knowledge of IEC 62304 (FDA Software Validation), FDA quality systems regulation, and FDA 21 CFR part 11
Software/equipment/process/test method validation experience
Ability to support the regulatory team in writing, validating, and testing requirements
Experience with analytical and software validations and qualification
Ability to represent Quality and Regulatory on multiple software projects
Quality Analyst with a strong software background
Ability to identify Quality Management System (QMS) needs
Ability to support production and the production team
PREFERRED KNOWLEDGE
Experience in ISO 13485
ASQ Certification preferred
Greenbelt (or higher) in Lean Six Sigma


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