Job Listing Description

Quality Assurance Engineer - NC

Description:
Chipton Ross is seeking a Quality Assurance Engineer in Cary, NC.

Requirements:
o Serves as the Quality & Regulatory stakeholder for product development release team
o Ensures quality products are developed in accordance to governing regulations and processes
o Prepares all QARA product development deliverables
o Serves as key member of product risk assessment teams
o Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development
o Participates and supports various development activities including design reviews and Product Safety Committee
o Reviews and approves product design documentation
o Reviews applicable product documentation to ensure readiness for FDA submissions
o Support root cause analysis activities for the investigation of product complaints
o Assists in the planning and execution of verification and validation testing to ensure adequate test coverage for new products and sustaining design changes.
o Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes
o Responsible for managing all tool and process validations - reviews and approves all validation documentation
o Maintains Master Validation List (MVL) and facilitates annual review of MVL
o Reviews quality data to identify high priority issues relating to safety, complaints and systemic customer satisfaction
o Responsible for product change assessments, health hazard evaluations and product recall documentation
o Assists with CAPA investigations and ensures corrections and/or corrective actions for identified nonconformances are implemented
o Identifies and implements process improvement initiatives
o Works with other client entities to establish Communities of Practice in Risk Management, Software Quality Assurance, Software Development, and other strategic areas as required.

Requirements:
o 3+ years' experience in quality engineering / quality assurance role under the Quality System Regulation, medical device or other FDA regulated industry required
o Experience in New Product Development/ Medical Device Design Controls required
o Experience with software-based products required
o Extensive experience with quality tools and methods required (e.g. DFSS, root cause analysis, Software FMEAs, etc.) required
o Knowledge of Medical Device Directive, and/or ISO Quality System Standards desired
o Experience with requirements management tools and systems engineering concepts desired
o Medical device and software quality assurance experience preferred

Education:
o B.S. in Engineering (Electrical, Biomedical, etc.) or other technical degree

Schedule:
o Full time

 
Job Number: 172106
Job Location: Cary, NC
Rate: $29.41 to $40.44 DOE
Duration: 6 months
Input Date: 06/27/2018
Last Updated: 12/14/2018
Firm Name: CHIPTON ROSS
Attention: Billy James
Address: 343 MAIN ST
City, State: EL SEGUNDO, CA 90245
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: bjames@chiptonross.com
Website: www.chiptonross.com

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