Validation/Quality Engineer - Medical Device

Description Leading Medical Device company experiencing explosive growth. Extremely stable and strong! Attractive compensation and great benefits! Key responsibility is to provide oversight to ensure the process validation program is technically/statistically sound and regulatory compliant. You will work closely with Manufacturing, Manufacturing Engineering and Quality Engineering groups. Review and approve of Installation, Operation and Process Qualification (IQ, OQ & PQ) protocols and reports. Assess the above protocols for compliance to regulatory requirements and for statistical validity. Maintain database of validations performed and the results and provide reports regarding validation activities and status. Lead continuous improvement activities to ensure efficiency, effectiveness and compliance. Establish statistical based Inspection Procedures, design gaging and develop tools and techniques to measure pertinent product parameters. Participate in new product development programs, design reviews and approve design for quality/reliability requirements. Lead failure investigations and problem analysis and continuous quality improvement efforts. RequirementsBS Degree in Sciences, Engineering or other technical field. Minimum 6 years relevant experience in Quality, Manufacturing or Product Development Engineering. 5 years experience in the Medical Device and/or Pharma industry. NO EXCEPTIONS. 3 years experience in writing, reviewing and performing process validations. Strong Statistical ability. Machining knowledge/experience. Strong knowledge of blueprint reading, Geometric Dimensioning and Tolerancing, guage design, gauging methods, process/test method validation and risk assessment/failure modes and effects analysis. Working knowledge of metal cutting or metal forming industries. Demonstrate Project Management and excellent interpersonal and communication skills. TO BE CONSIDERED, PLEASE E-MAIL YOUR RESUME TO US IN WORD DOC FORMAT. MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Statewide, NY JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee SALARY: 65,000.00 - 80,000.00 USD /yearBONUS JOB REFCODE: 2202 COMPANY: Alliance Executive Search, LLC CONTACT NAME: Darrell PHONE: 919-554-0783