Senior Manager, Quality Systems – Medical Device QMS Leader

Alamar Biosciences, Inc.

Fremont (CA)

On-site

USD 180,000 - 200,000

Full time

3 days ago

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Job summary

Alamar Biosciences, Inc. is seeking a Sr. Manager of Quality Systems to own the Quality Management System (QMS) across medical device/IVD products.

You will lead regulatory compliance, audits, CAPA, change control and documentation; partner with R&D, Operations and Regulatory Affairs to embed quality at every stage of the product lifecycle. You will host FDA inspections and notified body audits, build a scalable QMS roadmap, and drive continuous improvement.

Qualifications

Bachelor's degree in engineering, life sciences or related technical field.
8+ years in quality within medical device or IVD, including 4+ years leading teams.
Deep knowledge of 21 CFR 820, ISO 13485:2016 and ISO 14971; EU MDR/IVDR and MDSAP.
Experience hosting FDA inspections and notified body audits; writing 483 responses.
Ownership of CAPA, document control, training, audits and management review.
Experience with eQMS implementations (MasterControl, etc.).
Strong writing skills for audit-ready procedures and reports.

Responsibilities

QMS ownership and strategy aligned with multiple standards and markets.
Lead multi-year QMS roadmap; drive remediation and gaps closure.
Select, implement and validate the eQMS; ensure CSV/11 compliance.
Manage document control, training, CAPA, nonconformance and audits.
Oversee supplier quality, internal audits, and management reviews.
Coordinate FDA inspections and notified body audits; lead responses to findings.
Define and report QMS KPIs to executive leadership.