172106 - Quality Assurance Engineer - NC
NC-North Carolina
$29.41 to $40.44 DOE
6 months
Chipton Ross is seeking a Quality Assurance Engineer in Cary, NC.

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.

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

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

o Full time

Billy James at bjames@chiptonross.com
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x340 or (800) 927-9318 x340

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.