Quality Systems Validation Engineer

G & A – San Francisco, California
Department G & A
Employment Type Full time

Medrio’s SaaS offering is a key component in the pipeline of getting lifesaving drugs to people who need them. We automate the clinical trial process and offer significant advantages over the competition, including 75% lower cost and quick, easy setup. Founded in 2005, Medrio is privately owned and currently experiencing geometric growth in terms of customers, revenue, and employees. 

We are looking for an enthusiastic and experienced Quality Systems professional to join our team!

 Responsibilities include, but are not limited to:

  • Serve on or lead a team in Computer Systems Validation.
  • Provide guidance or write Software Development Life Cycle deliverables.
  •  Promote and demonstrate GxP and FDA compliance.
  •  Execute supplier assessments, document supplier performance, and conduct audits.
  • Participate in investigations and propose corrective actions.
  • Recommend and implement improvements to the Quality System.
  • Understand FDA requirements that pertain to work performed at Medrio.

 Skills/Areas of Experience:

  • Bachelor’s degree and 5-10 years of experience in regulated industry, or an equivalent combination of education and experience.
  •  Background in software validation, information sciences and/or other relevant discipline and appropriate experience.
  •  Demonstrated working knowledge of quality systems requirements per relevant regulations, including 21 CFR Part 11 and the FDA Guideline “General Principles of Software Validation”.
  • Excellent communication and interpersonal skills.
  • Ability to liaise successfully with project teams.

 About Medrio:

At Medrio, we look for smart, capable, and conscientious people to help us expand our product capabilities, grow our business, and better serve our customers. Our employees love working for us because they get to develop, market, and sell a product that advances human health, and they enjoy many perks, including

  • An awesome, colorful HQ in downtown San Francisco with ping-pong, video games, and a kitchen full of healthy snacks.
  • Great benefits: We offer medical, dental, vision, and life/LTD insurance, and we cover 100% of our employees’ health insurance premiums and 50% of dependent premiums.
  • Wellness: Medrio values our staff’s well-being. To prove it, we help cover the cost of your gym membership, and promote an atmosphere of work/life balance, including flexible work schedules and locations. 
  • Monthly events that range from baseball games to bowling to happy hour.
  • Weekly company-wide, beer friendly standup.

The Medrio team is made up of individuals with a wide array of skills and interests, but all have a passion for providing the best possible user experience for our customers. We value collaboration, ingenuity and creating a culture of excellence!

 

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  • Location
    San Francisco, California
  • Department
    G & A
  • Employment Type
    Full time
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