Senior Quality Engineer - Medical Systems and Manufacturing (ISO 13485)

| Chicago
About Us
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

About You

  • 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.

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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
    • PythonLanguages
    • SqlLanguages
    • ElixirLanguages
    • ReactLibraries
    • PhoenixFrameworks
    • MySQLDatabases
    • JIRAManagement
    • TrelloManagement
    • SalesforceCRM
    • OutreachLead Gen
    • Zoom InfoLead Gen

Location

We're in the West Loop, home to restaurant row and a bustling tech community!

An Insider's view of Fast Radius

What are some social events your company does?

I believe it’s important to build a strong community at our fast-growing company. There always seems to be something fun going on. Whether it's company-sponsored events like our holiday parties & potlucks or more casual get-togethers after work such as happy hours & sports leagues. These events have helped me get to know people in all divisions.

Kyle Tabatt

Senior Account Executive

How do you collaborate with other teams in the company?

Fast Radius has a strong culture of collaboration. Even the physical layout of the office supports that. The design engineers are next to the manufacturing engineers and the factory so it is easy for us to get feedback and brainstorm in real-time as parts are getting produced.

Izzy de la Guardia

Application Engineer

What's the biggest problem your team is solving?

With any rapid growth company, we have growing pains. Each team has its own goals, their own visions of success, and as such it's tough to stay aligned as one team. The Project Engineering team is working across the company on improving communication and workflow which ultimately ensures we keep the culture we've created long term.

Nick Tonini

Project Manager

What are Fast Radius Perks + Benefits

Fast Radius Benefits Overview

Competitive compensation and bonus structure
Comprehensive health care including dental and vision
Generous vacation policy
401K
WFH Flexibility

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Intracompany committees
Daily stand up
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Pair programming
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Health Insurance & Wellness Benefits
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Flexible Work Schedule
We offer flexible work schedules.
Remote Work Program
We offer flexible work from home opportunities.
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Stocked Kitchen
Happy Hours
Recreational Clubs
Professional Development Benefits
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
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