Quality Engineer - Medical Systems & Manufacturing
Chicago, IL /
Operations – Manufacturing /
We believe manufacturing is important not only for what it makes, but for what it makes possible for the world. Manufacturers have an important job to do, and it’s our job to provide them with the technology and expertise they need through the entire production process, from discovery and design to manufacturing and fulfillment.
We are looking for an experienced Quality Engineer to lead the development, implementation and maintenance of our quality system with a focus on medical devices. We are also looking for someone with the versatility to pivot supporting validation activities in the medical device space.
Please apply if you would be excited to grow into this role and make it your own, even if you don’t check all the boxes below.
About the Job
- Identify gaps from current system to compliance for ISO13485
- Create and install processes and documentation for preparation of the initial ISO13485 certification audit
- Support validation activities including IQ, OQ, and PQ requirements specific to medical device product development
- Own company training and maintenance of the QMS in accordance to ISO13485, FDA and other regulatory standards
- Actively manage the customer quality response and related closure of issues
- Execute quality planning for custom, on-demand projects and assure that quality capabilities and customer job requirements align and that gaps are identified
- Manage CAPA, FAI, IQ/OQ/PQ, and 8D reports
- 5-12 years of quality work experience with increasing responsibilities
- Experience with quality systems and medical device validation activities
- Experience with defining manufacturing inspection plans and processes for new medical device components
- Experience with ISO13485 standard Experience working for both medical device OEMs and contract manufacturers
- Experience with 510(k) and PMA submissions
- Experience with software validation is a plus
- Quick learner who can successfully deliver on quality tasks and objectives in an autonomous team-based work environment
- Ability to successfully work across the organization, address gaps, and drive for results in a high growth environment
- Inclusive attitude with excellent interpersonal skills
Every day you can expect to work in an inclusive environment that makes excellence possible, where great work and ideas matter more than seniority. We believe in experimenting fearlessly and learning from our failures—quickly. Our leaders have grown successful companies before, and they understand that businesses thrive when capable people have the freedom to solve problems without constraints.
We want you to come to work happy, healthy, and balanced so you can expect excellent benefits:
- Competitive compensation and bonus structure
- Comprehensive health care including dental and vision
- Generous vacation policy as well as a 401K plan
Fast Radius is proud to be an equal opportunity employer because diverse perspectives make for better products, better processes, and a better company. We encourage applicants from all backgrounds regardless of race, color, religion, sex (including pregnancy), sexual orientation, gender identity/expression, national origin, ethnicity, age, disability, Veteran status, or other protected status.