Quality Assurance Manager
TL;DR – Growing SaaS company in the Life Sciences sector seeking a technical, hardworking, and entrepreneurial teammate to help shape our development process
About our company and culture
At ZenQMS, we develop amazing quality management software for the whole enterprise. Our cloud-based platform, which includes modules for Document Management, Issue/CAPA, Training, Audits & Supplier Management, offers companies a tremendous opportunity to improve quality compliance and save money.
Our business is growing rapidly but built on an established and well-respected client base. Accordingly, we believe that we’ve been able to cultivate an environment that is both collegial and entrepreneurial, but still retains a bit of early-stage fun. Our employees range from recent college graduates to professionals with 20+ years of experience.
- Host and manage inbound client/regulatory audits, including organizing responses; Analyze/report on findings on quarterly basis
- Review and approve CAPAs and related issues, and enforce execution per established SOPs
- Review and maintain regulatory/standards compliance assessments (e.g., FDA, ISO)
- Organize process for generation of validation documents for releases, and review/approve documents in accordance with established SDLC
- Lead initiative to improve client audit materials and process/experience
- Lead outbound qualifications on key vendors (no travel)
- Organize/execute annual internal audit
- Launch initiative for HIPPA compliance; support GDPR activities
- Keep various stakeholders up to date on select active QA
- Identify process issues or inefficiencies and determine potential solutions; support other departments in process improvement, ensuring QMS and regulatory compliance
Qualifications and Skills
- Demonstrated passion for entrepreneurship
- Continuous improvement mindset
- Highly skilled in multi-tasking and managing priorities effectively
- Excellent analytical skills
- Team player who understands when to ask for help
- Prior experience with FDA or ISO regulated environments is a plus, but is not required
- Bachelor’s degree required
No recruiters please.