POSTED 23 Apr
Design Assurance Talent Community
at R&Q
OtherFull TimeUSA
As we are moving through uncharted territory, one thing that will remain consistent is the mission of R&Q Solutions: R&Q improves people's lives. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.
 
Providing world-class consulting services in a remote capacity is nothing new for R&Q Solutions as our consultant base is spread across 40 of our 50 beautiful states.  We remain committed to growing and engaging our talent network through these changing times.  While the upcoming weeks and even months remain unpredictable, we are continuing our REMOTE interview process and invite you to submit your information if you have an interest in learning more about our organization.  

We will be interviewing all levels of Design Assurance talent to interface with high-performing R&D and DA team members.  The Design Assurance department is responsible for design control deliverables, risk management activities and DHF compliance.

Primary Responsibilities

    • Understanding of technologies incorporated into design
    • Actively promote and participate in a cross-functional teamwork environment
    • Leads or participates in the review, translation, refinement and implementation of: design inputs, design outputs and requirements traceability matrices in compliance with internal procedures where gaps may be initially present
    • Participates with translation and creation of risk management deliverables (i.e. Hazard Analysis, FMEAs, Usability)
    • Applies sound, systematic problem-solving methodologies in identifying, prioritizing and communicating quality issues
    • Assist with regulated material assessments for EU MDR compliance 

Requirements

    • Bachelor level degree in engineering or another technical field
    • 2 - 15+ years of related work experience
    • At least 2 years of medical device industry experience required
    • Comfortable working within the unknown
    • Excellent written and verbal communication skills
    • Understanding of quality systems
    • Understanding of electrical safety standards IEC 60601
    • Understanding of configuration management
    • Demonstrated use of Quality tools/methodologies
    • Preferred medical device experience
Being an industry leader in client support is just the beginning for R&Q.  Providing a rewarding place to work is rooted deep in the core values of R&Q.  From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the “and means more” approach to employment.  At R&Q, you are not just another employee, you are a member of the R&Q family. Make your impact today! 

We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.
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