Total Hours/week: 40.001st Shift: Work days/hours: M - F 8am - 5pmClient: Medical Device CompanyNo H1b'sLocals only, must be able to go to the office at least 2X/weekPosition Sr. Quality EngineerLocation: Franklin Lakes, NJDuration: 12+ Months contractEmployment Type: Contract on W2 (Need US Citizens Or GC Holders Only)Overview Quality Engineering is responsible for product and service quality evaluation and control. Works cross‑functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process‑related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured. Demonstrates intermediate knowledge of quality engineering policies, principles and best practices. Demonstrates intermediate knowledge of FDA/ISO requirements. Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity. May act as mentor to less experienced team members. Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision. Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended.Requirements Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2015 and ISO 13485:2016Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexityAbility and skill to effectively manage multiple tasks and drive execution of change management plansAbility and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC Six sigma, additionally root cause analysis and project management techniques are routinely employedAbility to effectively write communications that ensures clarity, accuracy and consideration of the audienceAbility to speak with clarity and express points of view in a variety of settings; one‑on‑one interactions, group meetings, and formal presentationsAbility to listen to others; including associates, managers, peers and customers when making decisions and solving problemsExperience with complaint investigationProfessional certification preferred. Six Sigma, ASQ, AAMIExperienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programsPreferred: Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment or MS with 3 years of experience. Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field. Experience and understanding of electro‑mechanical instrumented systems. Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma preferred.Has in-depth experience, knowledge and skills in own job family.Applies knowledge and skills to a wide range of standard and non‑standard situations Works independently with minimal guidanceUsually determines own work prioritiesActs as a resource for colleagues with less experience#J-18808-Ljbffr