Quality Engineer - Medical Device Job Listing at Kelly Services in Germantown, WI (Job ID US3582840_BH9894236)

Description

Quality Engineer | Germantown, Wisconsin
Direct Hire | Onsite

A Kelly Engineering client has asked us to find a Quality Engineer to join their team to help develop quality systems, procedures, and controls that ensure medical products consistently meet performance and quality standards.

Duties/Responsibilities

• Identify, communicate, and implement quality improvements and solutions.
• Manage corrective actions, including customer complaints and internal issues:
  • Investigate root causes using Lean, Six Sigma, and statistical tools.
  • Coordinate sustainable corrective/preventative actions.
  • Document findings and update customer portals and internal systems.
• Lead the non-conformance process:
  • Evaluate suspect products and recommend disposition.
  • Coordinate containment, returns (RMAs), and rework activities.
  • Collaborate with customers on waivers or deviations.
• Maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory standards:
  • Support internal and external audits and corrective actions.
• Contribute to product development and realization:
  • Participate in design reviews, process planning, and risk analysis.
  • Review key product characteristics, gaging methods, and GD&T.
• Review and approve Engineering Change Notices:
  • Update quality documentation and control plans.
  • Process supplier and customer change notices.
• Serve as manufacturing liaison for quality-related issues.
• Approve medical device releases:
  • Conduct batch record reviews and generate Certificates of Analysis.
  • Release products in ERP system per customer and internal requirements.
• Support manufacturing operations:
  • Train personnel on inspection, rework, and customer specs.
  • Oversee inspection and testing activities.
  • Ensure customer approvals and maintain complete documentation.

 
Desired skills and experience

• BS in Engineering, Quality, or related technical field is preferred.
• 2-3 years of experience in a quality engineering role within the medical device manufacturing environment
• Understanding of quality standards and regulatory requirements: ISO 9001, ISO 13485, 21 CFR Part 820.
• Understanding of best practices for cleanroom gowning and cleanliness requirements for manufacturing within a cleanroom.
• Demonstrated experience in driving continuous improvement projects and using quality tools (e.g., DMAIC, 8D, PFMEA, SPC, MSA, DOE).

 
Client offers full benefits package not limited to:

• Medical, dental, and vision insurance
• PTO
• 401k retirement options

 
All applicants applying for this job opening must be legally authorized to work in the United States and are required to have US residency at the time of application. Sponsorship is not available for this opportunity. OPT or H1B Visa is not being accepted at this time.

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.

 Apply on company website