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Quality Systems Specialist
4 months ago
Position at Kymanox
Is Kymanox the right fit for you?
You want to make a difference and have an impact...
You enjoy having an influence in your day to day work...
You are motivated by working alongside a team filled with
subject matter experts that will help you learn and grow...
You wake up every day and do what you do
because patients deserve better.
If this sounds like you, you've come to the right place.
Kymanox is hiring a Quality Systems Specialist to provide direct operational support of the Quality Management System (QMS). The main objective of this role is to support senior Quality staff to effectively manage and maintain compliance of the QMS.
Primary Responsibilities:
- Support internal QMS initiatives, including eQMS administration and quality module implementation.
- Collaborating with cross-functional teams for establishing and maintaining QMS elements.
- Manage and maintain QMS elements such as:
- Deviation and CAPA
- Change Control
- Document Control
- Training
- Internal and External Audit support
- Author, review, and approve QMS documents
- Generate and perform QMS trainings
- Assist with the generation of quality metrics
- Other quality-supporting duties as required
- Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
- Minimum 2 to 5 years of experience supporting a medical device and/or pharmaceutical QMS.
- Previous experience with quality management software platforms.
About Kymanox:
Kymanox ('ki-mah-noks'), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pridebecause patients deserve better.
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
