Medical Device Quality Consultant Job Listing at Kelly Services in Springfield, MO (Job ID US3580326_BH9886388)

Description

Overview:
Our client is seeking a Contract Quality Engineer with medical device experience to support the successful implementation of ISO 13485 at our facility. This role is critical as they onboard a newly acquired medical customer and align their quality systems with regulatory and customer-specific requirements.

Key Responsibilities:

• Lead and execute ISO 13485 implementation activities, including process development and documentation.
• Perform comprehensive gap analyses against ISO 13485 requirements and generate actionable plans.
• Support internal audits and coordinate third-party audit readiness.
• Develop and revise quality documentation, including work instructions, procedures, and records.
• Collaborate with cross-functional teams (Quality, Operations, Engineering) to ensure compliance and understanding.
• Provide hands-on support in training staff on quality procedures and ISO expectations.

Required Experience:

• Proven experience in medical device manufacturing environments.
• Hands-on implementation of ISO 13485 standards.
• Strong knowledge of quality systems, gap assessments, and audit execution.
• Skilled in authoring work instructions, SOPs, and other controlled documents.
• Excellent communication and problem-solving skills.

Preferred Qualifications:

• Lead Auditor certification a plus.
• Experience working with contract manufacturing or plastics in medical device industry.

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.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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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