Quality Engineer--Medical Devices

Quality Engineer--Medical Devices Position is responsible for assuring quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards and Standards of the Medical Device Industry.The incumbent will be responsible for supporting new product development and product maintenance thru the use of Quality Engineering Skills.  The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.MAIN RESPONSIBILITIES• Provide Quality engineering support to all assigned projects, manufacturing facilities and suppliers. • Function as a Quality Representative on Design/Development and Manufacturing project teams. • Assess current operations for quality and compliance. • Develop & implement quality improvement programs • Ensure Design Control Elements are satisfied. • Assist/conduct Failure Investigations and problem solving sessions. Knowledge & Experience• Bachelor Degree Science or related field • 3 - 5 years Quality Engineering experience or 5+ years industry experience (Healthcare/Pharmaceutical) • Good understanding of Statistical Methods for Quality Assurance • General working knowledge of the 6 sigma process methodology • Thorough understanding of industry regulations:  QSR/cGMP, ISO QM standards • Good written and oral communication skills • Excellent problem solving and analytical skills • Ability to handle multiple projects simultaneously in an unsupervised environment • Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.