Quality Engineer Job Listing at Kelly Services in Tualatin, OR (Job ID US3600426_BH9964520)

Description

Job Title: Quality Engineer – Medical Devices
Location: Tualatin, OR (Onsite, Relocation Assistance Available)
Employment Type: Direct Hire
Salary Range: $115,000 – $120,000 + Benefits

About the Role

Kelly Engineering is partnering with a leading medical device manufacturer that is experiencing rapid growth. We are seeking a Quality Engineer to join the Quality Assurance team in Tualatin, Oregon. This position is responsible for ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and supporting quality activities across manufacturing and new product development.

Responsibilities

• Provide quality leadership for new product development, including design controls, risk management, validation, and design transfer.

• Develop and maintain quality inspection plans and acceptance criteria.

• Plan and execute validations (IQ/OQ/PQ), Gage R&R studies, SPC/DOE, and capability analyses.

• Drive CAPA and SCAR investigations to closure in a timely manner.

• Support supplier quality, including audits and vendor qualifications.

• Participate in MRB and lead investigations into nonconformances.

• Present quality metrics to management and support continuous improvement initiatives.

• Collaborate with R&D, Manufacturing, and Regulatory teams to ensure product quality and compliance.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing (candidates within a few courses of completion considered with strong experience).

• Minimum 2+ years of medical device quality engineering experience.

• Hands-on experience with design controls, CAPA/SCAR, process validations, and supplier quality.

• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820; EU MDR knowledge preferred.

• Applied statistics expertise (SPC, DOE, GR&R, capability studies).

• Excellent documentation, analytical, and communication skills.

Preferred Credentials:

• ISO 13485 Lead Auditor, ASQ CQE, Six Sigma Green/Black Belt.

• Experience with medical device sterilization (Gamma preferred).

Work Environment & Travel

• Onsite role, Monday through Friday business hours, some weekends as needed.

• Minimal travel (<20%), primarily supplier audits or training.

• Relocation assistance available for those that qualify.

Apply now through Kelly Engineering to be considered for this opportunity.

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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