**Duration: 12-month contract** **Job Description:** + Provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions. + Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc. + Lead discussion on blocked stock and open notifications in Material Review Board (MRB) + Assist with the investigation of Corrective & Preventive Actions (CAPA), non-conforming product, and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group. + Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, DOE, MSA, Validation Protocol development, review and approval and Control Plans. + Support Continuous Improvement activities and key plant projects. + Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans. + Implement proven inspection and metrology improvements and associated training. + Review and approve Project Design History Files. + Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO Standards. + Serve as a resource for performing internal audits to ensure quality system compliance. + Able to react to change and perform other duties as assigned. **Experience:** + **Strong experience in process and product validation is required.** + Experience in Quality Management System is also required, i.e., CAPA, Change control. + Minimum of 2 years of manufacturing quality engineering experience (preferably in a regulated industry such as health care, medical device, pharmaceutical, etc). **Skills:** + Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation + ASQ Certified Quality Engineer/ASQ Certified Quality Auditor + Proficiency and/or working knowledge of databases and programs (i.e. SAP, EtQ, Access, Excel, Microsoft project, Minitab) + Thorough knowledge of the regulatory industry requirements ISO13485, ISO15378, Quality Management Systems, Regulation CFR 21 part 820, GDP / cGMP. **Education:** Bachelor’s Degree in engineering. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.