Sr. Quality Engineer

Company: Kelly Services
Location: Germantown
Posted on: April 9, 2021

Job Description:

Quality Engineer --(Grafton, Wisconsin)--Client in medical devices is currently seeking a Quality Engineer, an engaging leader to support to the manufacturing process within a team oriented, customer-driven organization. This position will provide quality support to the facility relating to corrective actions, process control, statistical analysis, process and test method validation, and continuous improvement. ----Responsibilities:Lead the generation, execution, and review of qualification/validation protocols and reports.--Lead the planning, implementation, and effectiveness verification of corrective and preventive actions.--Assist production with the investigation of component and finished good non-conformances.Assist supplier management and Quality Control with the investigation of sourced raw materials, components, and finished goods.--Monitor and investigate deviations from Quality System processes.--Review continuous improvement of quality systems, procedures, & executed records to determine gaps and to identify areas for improvement.--Review proposed technical changes and identify related impact to processes/procedures/ materials etc. Generate and maintain specifications for raw materials, components, & finished product.Perform risk assessments (FMEA, etc.) and initiate action plans.Assist the QA Manager with gathering and analyzing data to determine performance of Quality and Operations (metrics).--Oversee the site calibration program.--Qualifications:Bachelor of Science Degree in engineering or science.ASQ-Certified Quality Engineer or Six Sigma Black Belt Certification desired.--Seven years of quality or engineering experience in an FDA regulated environment.--Three years process validation experience (IQ, OQ, PQ), test method validation experience and maintenance of master validation plans.Three years' experience in sterile packaging and ETO sterilization.Experience within a high-volume manufacturing facility strongly preferred.Excellent verbal and written communication skills.--Ability to organize, prioritizes, and perform multiple tasks with minimal supervision.A sense of urgency, good attention to detail, and follow-thru.--Working knowledge of Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.--Why Kelly--?Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]

Keywords: Kelly Services, Milwaukee , Sr. Quality Engineer, Other , Germantown, Wisconsin