Sr. Qa Specialist - Remote

Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.

Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.

• Support other departments with CAPA process, including, creation and follow through to completion, ensuring appropriate documentation is captured
• Lead, assist, and/or mentor other Quality Assurance Specialists
• Approve event intake tickets (EITs)
• Ensure company compliance with GxP requirements, company policies and procedures, ISO standards, and MDD/MDR requirements
• Ensure adequacy of current quality assurance standards and recommend enhancements
• Interpret and comply with quality assurance standards
• Ensure ongoing abidance by industry regulatory and quality requirements
• Carry out appropriate corrective procedures from internal and external audits
• Other duties as assigned
• Ensure risk management procedures are utilized correctly
• Gather and organize statistical quality data
• Report on results of quality activities
• Document quality assurance activities, including, internal audits and CAPAs
• Analyze non-compliance issues to identify trends and propose resolutions
• Identify quality areas for improvement

• Comfort working across teams in a fast-paced environment
• 5+ years of experience in a quality role or a combination of education and experience
• Ability to handle sensitive information with the highest degree of integrity, discretion and confidentiality
• Analytical, problem-solving, and decision-making skills
• Experience working in a quality capacity (pharmaceutical or medical device preferred)
• Ability to write, speak, and interact clearly and professionally
• Experience working in an ISO environment

Minimum Level of Education:

• Bachelor’s degree in a related field

Preferred Degree/Certification:

• ASQ Certified Auditor
• Six Sigma Green or Black Belt

#LI-REMOTE

Medable, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

U.S. employees and contractors, and International workers with travel to the U.S. must have a willingness and ability to provide proof of completed COVID-19 vaccination prior to start date. All strongly held beliefs, religious, medical, and other legally recognized exemptions regarding vaccination status will be considered.