Quality Engineer

　　Up to 49 an hour

　　Plymouth, MN

　　Potential Temp to Perm Opportunity

　　Position is responsible for direct interaction and support and customer quality management, assuring that QSRs and QMS are in accordance with regulatory standards and promote continuous improvement of the Quality System. Other duties may be assigned on an individual basis: This position will report to the Director/Quality Assurance. This role complies to FDA QSR 21 CFR 820 , ISO 13485 requirements and adheres to the Quality Management System.

　　ESSENTIAL FUNCTIONS: Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures SOPs . Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group. Develop and maintain the pFMEA process for manufacturing. Support/participate in regulatory agency and customer quality audits. Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability. Participate in initiating nonconformance report, Containment, root cause investigation, dispositions and implementation of CAPA . Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues. Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements. Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R R studies. Provide quality engineering support to sending sites during project transfers. Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.

　　QUALIFICATIONS: BS/BA degree with a scientific/engineering emphasis required. AQS Certified Quality Engineer or MS in Medical devices engineering, Engineering Management or Mechanical Six Sigma Green/Black belt recommended Minimum of 3 years’ experience with MS in a related regulated medical device environment. Catheter/MI experiences an advantage.

　　COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies: Values: Integrity, Accountability, Teamwork, Innovation Excellent verbal and written communication skills Ability to work independently Ability to manage tight timelines and changing priorities Excellent problem-solving techniques Proficient with Microsoft office applications

　　PHYSICAL DEMANDS AND WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

　　PHYSICAL DEMANDS: Physical Activity - Repetitive motions: Making substantial movements motions of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. Physical Requirements

　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Engineering?

　　Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.