Quality Engineer

Must have hands on validation of Injection Molding/Pharmaceutical/Medical Device experience QUALITY ENGINEER Summary: Provide support in the development and maintenance of company's quality systems. Support activities related to the development and qualification of new product development for medical device components and assemblies as well as supporting existing products. Essential Duties and Responsibilities *Write FMEAs, review and write protocols and reports for new products *Ability to multitask on a variety of Quality System compliance and improvement initiatives in a hands-on dynamic environment and be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes. . *Responsible for the facility measurement equipment calibration and maintenance program. *Collects, collates and analyzes manufacturing data for warranty and non conformance to determine and report product quality trends. Conducts analysis of inspection and tests of a routine degree of complexity and provides recommendations accordingly. Develops quality control inspection requirements and techniques to achieve measured improvement. *Implements the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action. *Support Receiving, In- process and Final Inspection of various components and sub assemblies for medical device products to support quality compliance and shipment goals as workload requires. *Assist in the development and implementation of Quality System processes. *Attend various product meetings with Engineering, Sales, Support, Marketing, and customers to address product requirements, customer concerns and training issues. *Work toward and support Company/Department/Team goals including; QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate. *Qualify and implement document changes involving product or process changes *Coordinate the reporting, analysis, and resolution of material non-conformance incidences *Provide support in the timely resolution of product complaints and/or safety issues *Conduct quality audits and develop subsequent preventive action programs *Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies. *Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non-compliance and ensure timely/effective corrections and /or corrective preventative actions are implemented *Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests. *Report MRB performance metrics and maintain corrective action database. *Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions Education, Training, Skills and Experience Requirements: *7 years' experience in Quality, medical device, regulatory, and or a medical device manufacturing environment. *BS in Bachelor of Science in Quality, Business, Mechanical Engineering, Engineering or related field. *Certification, CQE, CQA a plus. *Experience as an ISO Lead Auditor desirable *Must be able to communicate effectively at varying technical levels with a customer audience. *Hands-on manufacturing experience in mechanical or medical device assemblies. *CMM, MicroVu, Vision Systems Programming experience *Working knowledge of U.S. and international medical device regulations is desirable *Working knowledge of desktop computer office software, Visio Tools, CAD software and e-mail is required *Excellent verbal and written communication skills *Flexibility to handle multiple tasks and meet time lines. *Excellent analytical and problem-solving skills combined with a strong technical presence.