Quality Manager, R&D & Operations
Location: Seattle, WA (Onsite)
Reports to: Executive Leadership
Compensation: Base salary range $125K-$155K DOE
Role Overview
As a critical leader in a high-growth IVD medical device company, you will scale and manage a robust Quality Management System (QMS) compliant with ISO 13485, MDSAP, and EU MDR. This role combines hands-on QMS ownership with the leadership and mentorship of a dedicated Quality team.
Key Responsibilities
- Team Leadership: Lead, coach, and mentor direct reports to foster a culture of accountability and continuous improvement.
- QMS Ownership: Define, implement, and scale the QMS in compliance with FDA 21 CFR 820 and ISO 13485.
- Quality Events: Manage and trend deviations, nonconformances, CAPAs, and complaints; ensure effective root cause analysis.
- Audit Management: Lead internal, supplier, and external audits (ISO/FDA); drive inspection readiness and remediation.
- Compliance & Documentation: Author and maintain SOPs, oversee document/change control, and serve as the eQMS owner.
- Operational Support: Oversee supplier quality and Contract Manufacturing Organizations (CMOs).
Qualifications
- Education: Bachelor’s degree in science, engineering, or a related field.
- Experience: 6–9 years in Quality Systems within a regulated medical device or IVD environment.
- Leadership: Proven track record of managing and developing direct reports.
- Technical Knowledge: Deep expertise in ISO 13485, 21 CFR 820, and ISO 14971.
- Systems: Proficiency with GMP-compliant electronic systems (eQMS).
- Travel: Ability to travel up to 20% to supplier and CMO sites.
Preferred Credentials
- ASQ Certified Quality Auditor (CQA)
- Regulatory Affairs Certification (RAC)
