Invitae
Invitae develops tests that detect genetic variations associated with cancers and inherited disease.
Boulder, CO

Quality Engineer - PCM at Invitae

| Greater Boulder Area
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Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve! We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

Position Summary:

The Quality Engineer - PCM, reporting to the Quality Manager, will support tech transfer, production scale-up, and Quality operations activities for the Personalized Cancer Monitoring (PCM) product division, and implement the Quality Management System (QMS) to ensure the company’s medical devices are manufactured under applicable regulations. The Quality Engineer will also be tasked with developing quality processes in a high-throughput Manufacturing environment, investigating quality issues, and implementing continuous improvement activities to ensure that production rates are scalable while maintaining Quality standards.

This role works onsite at our Boulder, CO location. 
Responsibilities:
Job performance will involve a variety of activities including:
    • Serves as the Quality Engineering representative for daily manufacturing processes, completing product releases and investigations while supporting new product development and tech transfer projects.
    • Influences across Quality System functions, including, but not limited to, design, production, assay development, document control, risk management, etc.
    • Develops, implements, and evaluates tools, systems, and methods for product/process improvement and conformance.
    • Applies Lean/Six Sigma principles to identify and implement improvements in a rapidly-growing manufacturing environment to increase capacity, reduce lead-time, and improve process flow.
    • Provides technical guidance and quality compliance for multiple areas of the quality system to ensure process and product quality, and provides strategic Quality representation across teams.
    • Identifies and supports quality test methods, inspection criteria, risk assessments, and other processes to ensure compliance to regulatory standards.
Requirements:
  • 5+ years of Quality experience in an FDA-regulated environment
  • Bachelor's degree in an Engineering or Scientific field
  • Expertise in Quality System requirements, including ISO13485 and 21CFR820
  • Lean/Six Sigma Green Belt certification, preferred
  • ASQ CQE certification, or similar preferred
Key attributes:
  • Attention to detail with a strong ability to create and review technical documentation
  • Ability to interact with multiple subject areas, and communicate clearly and effectively verbally and in writing
  • Ability to work independently, and utilize good problem-solving skills
  • Ability to multitask and work within a fast-paced dynamic team

In Colorado, our competitive compensation package includes a base salary starting from $86,160.00. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

  • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
  • Paid time off, holiday pay, parental leave, and other health and wellness supports

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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Where we are

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

Technology we use

  • Engineering
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • RubyLanguages
    • SqlLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • ReactLibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • MongoDBDatabases
    • PostgreSQLDatabases
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What are Invitae Perks + Benefits

Invitae Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Unconscious bias training
Diversity manifesto
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Restricted work hours
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning

An Insider's view of Invitae

What’s the vibe like in the office?

Collaborative - when I walk through the Invitae office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Invitae. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

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