Description :
ESSENTIAL DUTIES The Quality Engineer is responsible for providing input and guidance to R&D, Manufacturing Engineer and Manufacturing. The products that are developed are very mechanical in nature so a strong background in Mechanical Engineering concepts is an absolute requirement. The candidate will also be responsible for quality assurance and regulatory compliance activities associated with design control, new product introduction and modification to released products. The candidate must be familiar with very precise machined and molded technologies and a demonstrated ability to manage quality activities of contract manufactures. Major Duties and Responsibilities: Represent Quality as part of Design Teams, New Product Introduction and Design Reviews Define Quality Plans and Quality Goals for projects Actively participate in all aspects of Design Control, FEMA, Hazard Analysis, Sterilization, Design Reviews Develop and manage Master Validation Plans and details components validation using IQ, OQ and PQ Develop inspection sampling plans and test methods Analysis of data on metrics of high volume production components Failure analysis on mechanical components in support of product design, production issues and product complaints. QUALIFICATIONS Skills/Abilities: Excellent communication skills, both written and oral A minimum of 5 years in the medical device industry Experience in the Orthopedic, Spine or Dental Implant market a plus Other: This position will have to travel to manage contract manufacturers and suppliers. Travel time would be estimated to be 15% of the time. Travel can be planned most of the time. Education/Certification: B.S. degree in Quality Engineering or related technology field (Mechanical Engineering strongly preferred)