Senior/Staff Quality Engineer (Assay/IVD Design Controls)

| Chicago | Hybrid
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Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are looking for a Senior/Staff Quality Engineer (Assay/IVD Design Controls) who will aid in the implementation of the Quality Management System framework, focus on product development, design controls, and risk management procedures.This position will report to the VP of Quality Assurance. 

Responsibilities

  • Represent QA on product development teams focusing on assay, reagent, and automation development. Responsible for guiding teams through design controls.
  • Lead risk management activities on cross-functional teams and ensure the required deliverables are documented properly in Design History Files (DHF).
  • Collaborate with Product Development, Operations, and Supply Chain teams on the transfer of reagents and consumables to suppliers.
  • Review and approve Tempus’ documentation that is consistent with design controls procedures and regulations. Documentation may include but is not limited to DHF documents such as product requirements, design and development plans, verification and validation plans and reports, design transfer documents, and risk management plans and reports.
  • Lead and participate in activities to establish and maintain Tempus’s product development, design controls, risk management, and supplier management systems.
  • Maintain knowledge of the evolving regulatory landscape for Laboratory Developed Tests (LDTs), Companion Diagnostics (CDx), and Next-Generation Sequencing (NGS) based tests.
  • Provide quality support for internal/external inspections and product submissions/approvals as needed.
  • Perform other related duties and responsibilities as assigned.

Required Qualifications

  • Bachelor’s Degree in Engineering or related scientific discipline.
  • 5+ years in Quality and/or Development experience in product development, product transfer, verification, validation under Design Controls in the life sciences industry, preferably in a FDA regulated medical device/IVD environment.
  • Previous Quality engineering experience and demonstrated use of Quality practices and methods.
  • Strong working knowledge of FDA QSR/cGMP and ISO regulations (e.g., ISO 13485).

Preferred Qualifications

  • Strong team player with demonstrated track record of success in a cross-functional team environment.
  • Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgement in support of QMS activities.
  • Ability to influence and be the voice of Quality when working with various groups in the organization.
  • Manages change well. Adopts a continuous improvement orientation to the role.
  • Excellent communication and interpersonal skills. 
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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
  • People Operations
    • GolangLanguages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • SqlLanguages
    • SwiftLanguages
    • GCPLanguages
    • ReactLibraries
    • ReduxLibraries
    • Node.jsFrameworks
    • SparkFrameworks
    • TensorFlowFrameworks
    • Microsoft SQL ServerDatabases
    • MySQLDatabases
    • PostgreSQLDatabases
    • SQLiteDatabases
    • LookerAnalytics
    • TableauAnalytics
    • FigmaDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • Google SlidesManagement
    • JIRAManagement
    • TrelloManagement
    • DocuSignCRM
    • SalesforceCRM
    • MarketoLead Gen
    • Google HangoutsCollaboration
    • SlackCollaboration
    • ZoomCollaboration

Location

Our Chicago office is located in downtown River North. Right on the river and close to neighborhoods like Fulton Market, Central Business District, Lincoln Park, and Streeterville, it's a lively area with convenient transportation access and is home to many bars, restaurants, and coffee shops.

An Insider's view of Tempus AI

What’s the vibe like in the office?

The casual setting here in the Chicago office makes everyone less intimidating and more approachable. It's nice to be in an environment where our day-to-day work actually makes a difference, I feel valued. Tempus is also great at welcoming everyone with different backgrounds.

Alexis

Clinical Lab Associate

How do you collaborate with other teams in the company?

I collaborate with various hiring teams on a daily basis. Through weekly meetings, strategic planning, events, and messaging, hiring teams and I have built a collaborative hiring process and have become trusted partners to bring top talent to Tempus. We rely on honest communication, shared goals, and the right tools to set us up for success!

Emma

Recruiter

How does the company support your career growth?

I am always looking for the next opportunity to grow my career, and Tempus has a wealth of opportunities in many departments. Through emerging leaders programs and ongoing conversations with my managers, Tempus has always been supportive in guiding me to find work that is fun, interesting, and maximizes my potential.

Aaron

Senior Operations Manager

What are some things you learned at the company?

One of the things that molded my growth was seeing how much thought goes into the decisions, and how much leadership seeks feedback from the people around them, to help understand the impact of decision-making. Just being a sponge in the room is inspiring. I adapted the styles of many leaders here and use that to create my own leadership style.

Anita

Laboratory Operations Manager

What are Tempus AI Perks + Benefits

Tempus AI Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Employee Assistance Program (EAP)
Pet Insurance
Company Cafeteria with Breakfast, Lunch & Grab & Go Options
Stocked Kitchen with Snacks
On-Site Barista
Discounted Gym Membership
Discounted Divvy Membership
Diversity & Inclusion Initiatives
Team & Company Outings

Culture
Volunteer in local community
Open door policy
OKR operational model
Team based strategic planning
Pair programming
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
Flexible work schedule
Remote work program
Diversity
Highly diverse management team
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Pet insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
Company equity
Charitable contribution matching
Child Care & Parental Leave Benefits
Generous parental leave
Family medical leave
Vacation & Time Off Benefits
Unlimited vacation policy
Generous PTO
All staff in Tempus’ laboratories are subject to Tempus’ separate laboratory PTO policies.
Paid volunteer time
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Office Perks
Commuter benefits
Company-sponsored outings
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Meditation space
Mother's room
Onsite gym
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

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