Job Title: Senior Quality Compliance Writer
Department: Product Management
FLSA Status: Exempt
We are a small software company in Rochester NY on a mission to transform and improve medical decisions through augmented thinking and timely visualization – to become the most relied upon intelligence platform for improving medical decisions by healthcare professionals and lay people alike.
This position is responsible for coordinating all necessary activities related to the Quality Management System (QMS) and associated documentation. This role is part of a multidisciplinary team supporting development and commercial activities.
We’re looking for a person who shares our passion for developing quality software that helps make a difference in people’s lives.
Duties and Responsibilities
- 70% Quality Management System
- Primary responsibility – Own and update Quality Management System to comply with business needs, markets, and regulatory guidance.
- Understand and maintain all pertinent standards, regulations, requirements for business as it applies to our QMS.
- Oversee Quality metrics and organize quality activities to measure the QMS performance and address issues as they arise or are trended.
- Manage, CAPA, training, and documentation using electronic system
- Organize responses to audits and technical documentation reviews
- 20% Assist with internal and external quality audits when needed
- 10% Development and documentation of various other procedures and processes
- All other duties as assigned
- Minimum bachelor’s degree in business or science discipline and/or 5 years’ experience in advancing and maintaining Quality Management Systems within a regulatory environment.
- Strong project management capabilities
- Excellent written and verbal communication
- Ability to produce accurate work in a timely manner
- Strong computer skills – experience with document control software is a plus
- Experience in Clinical or Healthcare fields a plus
- Experience with HIPAA compliance and Security (HiTrust) Standards a plus
Other desired skills or experience:
- Experience in medical or healthcare fields
- Experience in a regulatory compliant environment a plus
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to use hands and fingers and reach with hands and arms.
We care and we have FUN at VisualDx! We provide the following:
- Time off: Vacation, Sick leave, and Holidays
- Benefits: Health Insurance, Dental Insurance, Vision, 401K and more
- Caring & Self-Care opportunities: Social Causes Committee, Wellness Wednesday, Diversity, Equity, and Inclusion Team, weekly yoga & meditation sessions
- Company Events: Picnics, happy hours, catered lunches, Festivus and our newest tradition -Treat Yo Self Day!
- Pets: We’re pet people and usually have a few office dogs visit each day
VisualDx is committed to a diverse and inclusive workplace. We are an equal opportunity employer and do not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Minorities are encouraged to apply.