Director of Quality

New Today

Kelly, in partnership with an amazing non-profit company, is looking for a Director of Quality in Indianapolis, IN. Our ideal candidate will have a background in medical devices as well as new product rollout.
This is a direct hire position meaning you will hired permanently with our client and offered their benefit and vacation package upon hire.
Benefits:Health, dental and vision insurance 403b plus 100% match up to 7.5% 80 hours of vacation time, 80 hours of PTO and 11 paid holidays
Details:8:00 am to 5:00 pm Monday through Friday $120,000 - $135,000 annually
Job Description:Oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) from development to operations, ensuring compliance with industry regulations and standards. qualifications. Ensure ongoing compliance with FDA, ISO 13485, ISO 9001, and other applicable regulations and standards. Lead internal and external audits, including but not limited to ISO audits, FDA inspections, and supplier audits Serve as the quality representative in design and process validations, risk assessments, and regulatory submissions. Mentor and lead QA/QC team, ensuring continued development and compliance Direct the CAPA process, including root cause analysis and effectiveness verification. Oversee document control, training programs, complaints, cleanroom certification, calibrations, and change control. Establish and monitor quality metrics, KPIs, SOP’s, and management review activities. Collaborate cross-functionally to support product development and commercialization. Develop supplier quality systems and manage supplier audits and compliance
Requirements:A minimum of 10 years’ experience in Quality Assurance with an emphasis on working with medical devices or a similarly regulated environment including a demonstrated thorough knowledge of medical device quality systems with direct experience of ISO 9001, ISO 13485, and 21 CFR Part 820 At least five years’ work experience in a leadership role managing the Quality Assurance function
Immediate opening, apply now!
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 for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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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.
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Location:
Indianapolis

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