Quality Assurance Manager

Quality Assurance Manager at Radiant Dev Quality Assurance Manager at Radiant Dev in Medina, Washington Posted in 8 days ago.

Type:

full-time

Job Description:

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)