Randstad Quality Engineer in Newark, Delaware
Newark, DE Salary:
US$ 60,000 - US$ 80,000 per year Date Posted:
Monday, October 10, 2016 Experience:
3 years Job Type:
Quality Engineer, Newark, DE, Reporting to the VP of Quality, this position is responsible for the implementation and continued use of statistical techniques to evaluate, optimize and control processes and products. Additionally, supervises the testing and development of new products and supervises the testing of current products in order to improve them. The position may supervise the Lab Technician(s) performing required tests by the government of new products for compliance with regulations. BA degree required. Med device experience desired.
Responsibilities for the Quality Engineer
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
Establish effective corrective action plans with DMRs (defective material reports)/nonconformances. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure QA and ISO compliance in all areas of responsibilities.
Will be responsible for developing and implementing and supporting engineering in the following: master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet and ISO (International Organization of Standardization) and customer requirements.
Interacts with customers and suppliers to assist with planning and data evaluation.
Requirements for the Quality Engineer
Must have a Bachelor of Science degree in engineering or a technical field, or a minimum of three years of college in the sciences and engineering required.
3+ years of experience in manufacturing operations, with at least two years in a function focused on the use of statistics and experimental design and must have a one-two years experience in a supervisory position.
Medical device experience desired but not required
Must have strong data analysis skills, including experience with computer statistical programs.s.
ISO 9001 is required, ISO 1345 would be a plus
Strong root cause analysis experience, 5 Why, 8D, Six Sigma
Must have strong analytical and technical writing skill
Experience with sampling plans, validations, test methods
Job Number: 125956