Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

　　Title: Quality Assurance Engineer

　　Location: Kalamazoo, MI

　　Duration: 18 months Overview

　　The Product Acceptance Engineer will be the primary contact between Quality Assurance and Operations in The Finished Goods Operations.

　　Will provide expert QA and scientific support to Operations, in ensuring goals and objectives are achieved for The Finished Goods Operations.

　　The engineer will be applying product release process, for new projects coming into to FGO

　　Responsibilities

　　Complete Lot Review and Release for The Finished Goods Operations.

　　Complete Sterile load reviews

　　Continuous improvement and development of acceptance and inspection activities in The Finished Goods Operations.

　　Introduction of best practices in acceptance and inspection activities.

　　Co-ordinate with business units to ensure that acceptance and inspection activities are appropriately carried out.

　　Ensure that a consistent approach to acceptance and inspection activities is developed/maintained.

　　Co-ordinate with the business units in relation to non-conformance activities and root cause analysis associated with acceptance and inspection activities, to ensure a consistent approach.

　　Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.

　　Ensure regulatory compliance in area of responsibility to GMP of all medical device’s regulatory agencies (i.e., FDA, IMB and BSI).

　　Provide functional expertise to other support function on quality related issues.

　　Own and drive NC/CAPA’s related to process.

　　Interface with Suppliers for quality Issues.

　　Work cross functionally with such groups as Regulatory, Design Division and Operations to ensure all issues are successfully resolved

　　Support The Finished Goods Operations in addressing quality metrics, e.g. NC, CAPA, , , Process Changes, , Quality Alert, Product Holds and Recalls.

　　Support site during External Audits. (i.e., FDA, IMB and BSI). Support / act as local subject expert for review, creation and training of divisional/corporate procedures.

　　Responsible for input to Quality Metrics.

　　Ensure system transactions

　　Required Qualifications

　　Bachelor’s degree in Science or equivalent

　　Minimum of 4 years’ experience in a QA role

　　Good level of technical and analytical skills

　　Capable of working as part of a multi-discipline team across multiple continents and time zones

　　Ability to work in a fast paced, dynamic and results motivated team environment

　　Ability to work independently to achieve desired goals and results

　　Preferred Qualifications

　　Previous experience in Lot Review and Release would be an advantageAdditional Information

　　Monday – Friday / 8:00am – 5:00pmImportant information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone ( [email protected] ) for immediate consideration.

　　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.