Summary: Seeking a Quality Engineer with expertise in medical device OEM or contract manufacturing environments to develop and implement quality processes.

Requirements: BS Degree in Biomedical or Manufacturing Engineering 3-5 years' experience in a quality department within an ISO registered environment Experience with ISO 13485 & ISO 9001 standards Knowledge of process capability, production, equipment, and assembly effects Proficiency in problem-solving methods (5Y, Fishbone, 8D) Self-managed from a satellite operation

Preferred Skills: Six Sigma certifications (green belt or higher)

Responsibilities: Develop and implement quality processes for new programs and sustainment business Involve directly in manufacturing process development and improvement Resolve quality issues through root cause analysis and corrective actions Implement preventative actions and continuous improvements Manage non-conformance area including inventory disposition Purchase and review gage equipment certifications and calibrations Coordinate daily inspection, measurement, testing, and approval of components and products Use quality management system software daily and conduct audits

Pay Details: $70,000.00 to $85,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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