Quality Assurance Manager

Narberth, PA

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.

Your responsibilities

  • 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

To apply

No recruiters please.