Quality Management System Specialist
Enlitic
Other (specify in description)
1 to 3 years
Other
02 Jul 2022
About Us
Enlitic is shaping the next generation of diagnostic healthcare tools to help patients around the globe. Using AI and deep learning, we help Radiologists identify disease and medical issues more accurately and earlier. We believe we are addressing one of the largest social impact opportunities in healthcare with our technology deploying around the globe. Enlitic is attacking the hard, high-value challenges facing healthcare by developing solutions others are afraid to touch. We are dedicated to the development of impactful healthcare solutions. We have been featured on TED, CNN, WSJ, NY Times, Inc, Fortune, as well as named the 5th Smartest AI Company by MIT Tech Review.
Location
-Fort Collins, Northern Colorado Area.
Education
-Associated degree or equivalent work experience.
-Bachelor’s degree (preferred)
Experience
-1 year of work experience in the medical device or pharma industry.
-1 to 2 years of direct work experience within a quality management system, specifically change management/document control function.
-Experience with Qualio QMS Software (or similar Document Control System)
-Excellent interpersonal skills: ability to work in cross-functional teams.
-Ability to handle simultaneous tasks and prioritize accordingly.
-Excellent communication skills (written, verbal, and presentation).
-Proficiency with a full suite of MS Office, Adobe, and Google standard applications.
Position Responsibilities
-Manage Document Control System
-Provide support for training of document control processes
-Provides user and admin support as needed, including updating and drafting of documents in the document control system
-Perform final review of documents to confirm consistency across documents, clarity, readability and formatting
-Maintains associated data, log(s) and applicable records in accordance with record retention policies
-Administers the permissions for access to document and change control systems
-Manage and update as needed, Document Control Work Instructions, Reference documents and associated system templates
-Assure the periodic review and updating of quality documents by monitoring Document Review Due and Review Overdue reports. Contacts owners and escalates as needed
-Perform review of documents to confirm consistency across documents, clarity, readability and formatting.
-Escalates issues with documents or software systems as needed
-Processes new and revised controlled documents in accordance with established policies/procedures
-Maintain the corporate training matrix
-Interface with supervisors and managers for training requirements and assign to trainees
-Provides metrics/reports around management of controlled documents and training to controlled documentation
-Support supplier/vendor management with maintenance of supplier files
-Participate in corrective and preventive action process
-Participate in any validation activities of the QMS, audits/inspections, and select meetings as QMS SME
-Support QMS team in maintenance and continuous improvement of the quality management system
ISO/BMS Responsibilities:
-Understand and practice all requirements of EN ISO 13485:2016, ISO 13485:2016 MDSAP, QMS Manual, Process Flows and Work Instructions.
-Comply with applicable regulatory requirements (including but not limited to MDSAP participating countries and CE Marking).
-Support Internal and External audits.
Benefits
Our people love working here because they are challenged by unique and difficult problems in a nimble startup environment that is backed by five plus years of success in performance.
-Health, vision, and dental insurance
-Company paid Short Term Disability
-Company paid Long Term Disability
-Company paid employee Life Insurance
-Up to 10% 401k match
-Unlimited PTO
-$180 a month health and fitness stipend
Compensation
-Annual Salary Range: $50K to $65K depending on experience
-Annual Bonus
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