An opportunity for a high performing quality professional to take full responsibility and control of an existing Quality Management System and team for a small company working closely with C-Suite. With an FDA approved product on the market and significant VC funding, the high energy environment is a great place for someone to utilize and develop their quality & regulatory leadership skills.
- Lead a Quality department for a commercialized Class III implantable device that has 21 CFR 820 certified QMS (hands-on).
- Manage and guide a team of 3 experienced quality professionals across supplier, design, systems,, as well as oversee regulatory activities (not hands-on)
- Report progress updates to key stakeholders at the C-Suite level routinely as the company goes through commercial expansion.
- Initiate, review and approve investigations, risk assessments, deviations, CAPA, change records, etc. and recommend corrective actions/CAPAs related to cGMP and QMS issues
Required Qualifications & Skills
- 15+ years' in Quality Assurance & Regulatory positions within the Medical Devices industry.
- 5 years' Director+ experience, leading teams through audits, quality reviews, QMS improvements, implementing eQMS.
- Motivation to lead a team through continuous post market activities of a commercialized Class III Device.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.