Quality Engineer

Company: Aerotek
Location: Camarillo
Posted on: April 9, 2021

Job Description:

Description:Provides Quality leadership to product development teams in the areas of testing, verification/validation, design transfer, product quality/risk, and specification development.Owns and implements validation program, validation master plan, product qualification, and related documents and training.Quality contact/approver for requirements and documents which support design control, testing, verification, validation, and transfer of products including bioreactor control units (electromechanical), single use bioreactor vessels, and controller software.Manage or support qualification/validation studies for gamma sterilization, shipping/transport, packaging, and shelf life.Organize and manage product test samples and lab results for testing of particulates, endotoxin, biocompatibility, and extractables.Quality contact for validation of manufacturing process, facility, and equipment.Generate written assessments for impact to validation due to changes or nonconformances.Skills:Fda Compliance, Validation, Medical Device, Biotechnology, Six Sigma, iso 13485, CAPA, corrective action, Root Cause Analysis, Quality engineering, Process improvement, iq oq, change control, design control, non conformingTop Skills Details:ValidationLean / Six SigmaRoot CauseAdditional Skills & Qualifications:Bachelor's degree or higher in an Engineering field is preferred, a Bachelor'sdegree in a Science field is acceptable with 10+ years of relevant industryexperience10+ years in a Quality Engineering or Validation role, or 10 years in arelated role such as Product Development Engineering, ManufacturingEngineering, or industrial engineering.5+ years of experience working with products regulated byGMP/Biopharma (21 CFR 210/211, ICH Q7/10), medical device (21 CFR820, ISO 13485/14971), or medical products field (ISO 9001, ISO13485)2-5+ years using one or more engineering tools and methods such asCAD, statistical analysis (MiniTab, JMP, SigmaXL, or equivalent), statisticalsampling/acceptance methods (ANSI, MIL-STD, AQL), design of experiment,design control, DFM, etc.Experience Level:Expert Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Camarillo , Quality Engineer, Engineering , Camarillo, California