Job Description:
Kelly Science & Clinical has a new, permanent opportunity for a Quality Engineer in Walton KY!
Shift: M-F 7am-3:30pm
A Direct Hire Opportunity
Responsibilities:
\tDesign and develop complex new products, ensuring ISO 13485 and ISO 14971 standards are met.
\tFormulate procedures, specifications, and standards for products and processes.
\tParticipate in team meetings with cross-functional teams.
\tDetermine and validate inspection methods.
\tSupport manufacturing and engineering in supplier and process validation.
\tDevelop work instructions, device master records, test and inspection methods, and visual standards.
\tReview and approve team documents.
\tIdentify critical personnel, gauges, procedures, and materials for qualification.
\tCreate production reports, manage supplier assessment and approved supplier lists, and create audit plans.
\tManage nonconformance process, including trend analysis, corrective and preventive actions.
\tEnsure suppliers deliver quality products meeting specifications.
\tManage quality aspects of projects like timelines, prototypes, and testing.
\tContribute to cross-functional project teams, supporting all quality deliverables.
\tDrive problem-solving of product quality and process issues from development through release.
\tCommunicate with manufacturing to ensure design manufacturability and proper risk assessment.
\tCollaborate with project managers and customers to meet requirements.

Qualifications:

\tBachelor's degree in Mechanical or Biomedical Engineering or equivalent experience.
\tMinimum 5 years of experience in product quality within the medical device industry preferred.
\tKnowledge and experience in manufacturing processes of chemicals & plastics preferred.
\tProficiency in Microsoft Office and Manufacturing Management products.
\tStrong communication, decision-making, and problem-solving skills.
\tFamiliarity with cGMP requirements.
\tExperience with EPA, FDA regulations (i.e., 21 CFR 820, ISO 13485: 2016 & 21 CFR 211) recommended.

Pay will be determined based on title, education, and related industry experience. If you, or someone you know would like to be considered for this opportunity, please apply online today to discuss the next steps.
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\t\t\t\tAs 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 for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
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\t\t\t\tAbout 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 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.
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