Supplier Quality Manager at Invitae (Formerly ArcherDx)

| 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.

Responsibilities:

Job performance will involve a variety of activities (multiple as defined in the QMS) including:

  • Maintain compliance with all company policies, quality systems, procedures, per ISO 13485:2016, 21 CFR 820 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 in the context of Supplier Quality Management
  • Lead supplier monitoring per the QMS SOPs to ensure suppliers meet product quality requirements
  • Lead supplier development activities for continuous improvement of supplier performance prioritizing critical suppliers from a product and supplier perspective
  • Develop and lead supplier audit schedule, prioritized by risk
  • Implement quality agreements with suppliers
  • Perform and/or arrange for performance of supplier audits based on risk
  • Handle supplier corrective action reports and associated continuous improvements
  • Manage supplier change management per QMS SOP
  • Monitor and report supplier performance per QMS SOP, identifying trends and opportunities for continuous improvements at the supplier as well as from an Invitae design or manufacturing perspective
  • Act as a subject matter authority for the SQMP in customer and regulatory audits.
  • Liase with larger Invitae supplier quality organization to drive commonalities where appropriate
  • Handle the document archiving and retrieving process for supplier quality records
  • Work with cross-functional teams in problem-solving
  • Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
  • Safeguarding the privacy and security of protected health information and European Union personal data.
  • Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
Experience:
  • 8+ years of experience in a regulated industry with a minimum of 3 in Supplier Quality Management
  • Bachelor’s Degree (science discipline preferred); or equivalent experience
  • Ability to travel up to 20%
  • Previous audit experience preferred
  • Attention to detail
  • Ability to interact with multiple fields, and communicate clearly and effectively verbally and in writing.
  • Ability to use good problem-solving skills.
  • Excellent planning and organization skills.
  • Effective analytical skills.
Key attributes
  • Ability to work in a fast-paced and dynamic environment
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Strong communication and presentation skills
  • Driven to perform
  • Self-directed: needs little explicit direction
  • Able to coordinate, prioritize, and delegate tasks to efficiently move projects forward.

In Colorado, our competitive compensation package includes a base salary starting from $133,500 per year. 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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Technology we use

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Location

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

An Insider's view of Invitae (Formerly ArcherDx)

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

What are Invitae (Formerly ArcherDx) Perks + Benefits

Invitae (Formerly ArcherDx) 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
Someone's primary function is managing the company’s diversity and inclusion initiatives
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
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