QA Director
About Dot Compliance
Dot Compliance provides a ready-to-deploy, Salesforce-native eQMS with the industry’s first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance.
The company’s solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001.
Who we’re looking for
- Management of all Quality activities.
- Initiate, monitor and verify the effective implementation of the Quality Management System and Regulatory requirements that impact processes, products, or services.
- Maintain Dot compliance internal eQMS and Quality records.
- Responsible for validation methodology.
- Responsible for review and approval of relevant documentation such as SOPs, Validation documents
- Responsible for maintaining ISO 9001and other quality certifications.
- Responsible for supporting customers and prospects audits.
- Responsible for compliance with CFR part 11, Annex 11, and other guidelines.
- Work closely with sales to support deal closure, RFP response, Questionnaires …
- Work closely with product and RnD to deliver products to the Market.
Do you have what we’re looking for?
- B.Sc. degree or equivalent
- At least 5 years of experience as QA Manager in the Medical Device or Pharma \ Biotech, Healthcare arena - Mandatory
- Tech Savy and experienced in software validation methodologies and Cloud platforms.
- Highly skilled with managing and representing Dot in customer audits.
- High sense of ownership and ability to deliver independently
- Outstanding leadership, communication, interpersonal, and analytical skills with the ability to successfully lead multiple teams in a highly dynamic matrix.
- Excellent English (Verbal and Written), Outstanding communication skills.
- Must use practical, independent judgment, and organizational and problem-solving skills.