Quality Engineer

Kelly Services; Columbus (OH); On-site; USD 85,000 - 120,000; Full time

Job summary

Kelly Services is seeking a Quality Assurance Engineer in Columbus, Ohio to join a medical device-focused team. The role involves maintaining document control, managing QA processes for complaints and CAPA, and ensuring compliance with 21 CFR and ISO 13485 requirements.

The engineer will collaborate with leadership and cross-functional teams to enhance quality systems and product disposition. The ideal candidate has a medical device background, strong analytical skills, and proficiency with MS

Qualifications

• Medical Device Manufacturing background.
• Excellent quantitative and analytical skills.
• Ability to prioritize tasks in a fast-paced environment.
• Strong written and oral communication skills are required.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Bachelor’s Degree or higher in engineering or related field preferred.
• Knowledge of 21 CFR 803, 806, 820, ISO 13485 and all applicable requirements and regulations to support the manufacture and distribution of medical devices.
• Medical Device / FDA Experience.

Responsibilities

• Assist in maintaining an effective Document Control Management system, including SOPs and WIs for proofing, filing, scanning, archiving and retrieval of controlled documents.
• Manage Quality Assurance Processes for complaints, deviation, CAPA, recall or field action per 21 CFR 803, 806, 820 and ISO 13485.
• Ensure follow-up through corrective and preventative actions (CAPA).
• Manage risk assessments and follow-up activities with visibility of risks.
• Monitor and audit recall/field action activities for compliance with SOPs and CFR requirements.
• Strengthen quality awareness and support process improvements and audits.

Skills

Quantitative skills

Analytical skills

Prioritization

Communication skills

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Office

Job description

Quality Assurance Engineer (Columbus, Ohio)

Client located in New Albany, Ohio, Medical Devices, is currently expanding Quality Engineering Team, hiring two at the moment, additional roles may open in the fall/ early 2027- Entry Level, Mid- Level and Sr. Level Quality Engineers will be considered; Medical Device Experience required.

About our client & the team:

Products comply with applicable regulatory requirements as established by ISO 13485, U.S. Food & Drug Administration (21 CFR Part 803, 806, 820), MDR 2017/745, CMDR registered Quality Management Systems. Quality Engineers will work closely with the VP of Product Development to ensure that the quality system is implemented, monitored and maintained in accordance with all applicable regulatory requirements. All in all, Quality Systems in place could be better, could be implemented better, and new leadership is passionate about achieving!

Responsibilities:

Assist in the maintenance of an effective Document Control Management system, including relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the proofing, filing, copying, scanning, archiving, retrieval, and maintenance of all controlled documents and records required by applicable regulations.

Manage the Quality Assurance Processes to be followed in the event of a complaint, deviation, CAPA, recall or field action per 21 CFR 803, 806, 820 and ISO 13485. Coordinate and participate in investigations.

Ensure adequate follow-up through the implementation of corrective and preventative actions (CAPA) as required.

Manage risk assessments and follow-up activities and ensure visibility for potential risks.

Monitor and audit recall/field action activities to assure compliance with Standard Operating Procedures related to corrective actions, CFR requirements and customer complaints.

Strengthen quality awareness throughout the organization, support technical services and process improvements. Eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem-solving techniques.

Develop and maintain quality-related training programs and ensure implementation to minimize business risks.

Define and implement training system for employees related to the Quality Management System and job-related skills.

Provide Quality support to members of leadership team especially during audits and inspections.

Develop Quality metrics and goals; lead efforts related to the company’s quality vision.

Ensure that QA activities are properly staffed, operate in a cost-effective manner, and maintain an innovative approach based on productivity improvement and implementation of best practice.

Work with Manufacturing and R&D to ensure that products are developed and produced according to applicable regulations and standards.

Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements.

Maintain database(s) or spreadsheet(s) for the worldwide regulatory status of products.

Assist in the development and implementation of regulatory strategies and prepare FDA (IDE, 510k, PMA, 513G) and international submissions (CE Mark, TGA, CMDR, etc.) for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards, and guidance.

Maintain systems for labeling, promotional material, change control, and the documentation for these systems as required by domestic and foreign governments.

Monitor industry and regulatory trends to develop strategy and provide guidance related to these trends.

Advise technical, marketing, and sales personnel on regulatory requirements (e.g. Design Controls, CE Marking, IDE, IRB, Labeling, and Promotion).

Preferred Qualifications:

Medical Device Manufacturing background.

Excellent quantitative and analytical skills.

Ability to prioritize tasks in a fast-paced environment.

Strong written and oral communication skills are required.

Proficiency in Microsoft Office (Word, Excel, PowerPoint)

Bachelor’s Degree or higher in engineering or related field preferred.

Knowledge of 21 CFR 803, 806, 820, ISO 13485 and all applicable requirements and regulations to support the manufacture and distribution of medical devices. Medical Device / FDA Experience.

Desire to be a part of a team ensuring medical devices are safe, high quality, and compliant with FDA regulations.

Drive- to be curious, to want to be better, to Investigate product issues and customer complaints, help fix problems, maintain quality documentation, support audits and inspections, and work with engineering and manufacturing teams to ensure products are designed and built correctly. Be curious and passionate about making sure suppliers are happy and compliant, products are the absolutely best they can be!

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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-ljust 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.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affluent 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.