Kelly Services is currently seeking for a Quality Engineer for one of our top clients in Mansfield, MA.JOB TITLE: Quality EngineerINDUSTRY: Medical DeviceLOCATION: Mansfield, MADURATION: 6 Months (Temporary / Contract) - potential temp to permPAY RATE: $45 - $50 per hour W2JOB DESCRIPTION:Quality EngineerOnsite in Mansfield MAM-F normal business hourspotential temp to permexperience with handling complaints vs investigating.Looking for mid level QEPrimary function of the role is to address Complaints.This role supports maintenance and continuous improvement of the Complaint System, ensuring compliance with regulations and internal site and global procedures.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.Primary responsibilities are to:Ensure that all complaint investigations are performed, documented, and managed in a timely and efficient manner in accordance with all applicable internal procedures.Escalate relevant information on product complaints to appropriate management as necessary.Coordinate and/or attend meetings with appropriate departments for specific customer complaint issues.Plan, coordinate and execute the onboarding training of new complaint associates.Assess, process and close complaints in accordance with associated complaint handling procedures and Customer Quality expectations.Maintain and organize complaint product retention program at the investigation site in accordance with internal procedures and applicable regulatory requirements.Author and conduct technical complaint evaluations and investigations, including failure analysis.Review quality and manufacturing records, including DHRs, NCs, CAPAs, complaint records, failure analysis data and reports, and risk documentation as part of the overall complaint investigation process.Perform trending and risk analysis of received complaint investigations; determine if upper controls have been exceeded and evaluate risk to patient.Perform robust root cause analysis using appropriate technical skills, structured problem-solving methods, etc.Review complaint evaluations and investigations, including failure analysis.Establish, follow, maintain, and improve Quality Management System procedures, work instructions, and other processes related to areas of responsibility.Support and participate in Internal and External Audits as required.Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations and standards related to area of responsibility.Provide Complaints data analysis for metric reviews as applicable.Support and participate in post-market surveillance (PMS) activities as required.Identify and implement opportunities for continuous improvement.Perform other quality systems related duties as directed by Supervisor.DESIRED MINIMUM QUALIFICATIONSBachelor’s degree in an Engineering discipline (ex. – Mechanical, Electrical, etc.) required with minimum of 2-5 years’ experience in a regulated (i.e.- Medical Device) industry. Relevant experience may be considered in lieu of a degree.Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards related to Complaints and Complaint Handling.Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.Must be able to read and write in English.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 KellyWork 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 participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.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.
