Medrio is looking for an engaging and enthusiastic individual who is ready to join out Quality Systems team. We are looking for someone based in in our San Francisco or Pleasanton HQ offices. Some of the work can be done remotely.
Responsibilities include, but are not limited to:
- Lead a team in Process Improvements.
- Perform audits on critical suppliers.
- Facilitate the timely delivery of validation deliverables.
- Maintain the Vendor Files
- Monitor and track Vendor Performance
- Coordinate with department leaders on project deliverables.
- Participate in change management for patches and software releases.
- Recommend and execute process improvements.
- Lead a team in various corrective action projects.
- Facilitate the progress of multiple CAPA teams.
- Provide training to Medrio personnel regarding GCP, 21 CFR Part 11, and other important topics
- Establish metrics within the Quality System and monitor for improvement
- Work with Software QA, Development, Product and Support to achieve quarterly goals.
Skills/Areas of Experience:
- Bachelor’s degree and minimum 3 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.
- Good understanding of drug development and clinical trial process.
- Intermediate to advanced skills with Microsoft Word, Excel, and PowerPoint
- Some programming familiarity is helpful, but not required.
- Experience in both FDA regulation and in a software company is ideal.
Medrio’s SaaS offering is a key component in the pipeline of getting lifesaving drugs to the people who need them. We automate the clinic trial process and offer significant advantages over the competition: 75% lower cost, setup in days rather than months, and much better ease of use. Founded in 2005 we are privately owned, profitable, and are currently experiencing geometric growth in terms of customers, revenue, and employees. Now, about the good stuff...
- We have an awesome office replete with ping pong, foosball, and a kitchen full of healthy snacks.
- We are conveniently located two blocks from a BART station in downtown San Francisco.
- We enjoy monthly events that range from baseball to bowling to happy hour.
- We hold a company-wide, beer friendly standup once per week.
- We believe in wellness! Medrio covers the cost of employee premiums for medial, dental, vision, life and LTD insurance, gym membership, and we promote an atmosphere of work/life balance, including flexible work schedules that may include some work from home time.
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 are looking for smart, collaborative, creative, and conscientious people to help us expand our product capabilities and better serve our customers.