Quality Systems Manager

At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.

The Sr. Manager, Quality Systems owns the , ongoing compliance ,  and continuous improvement of the company's Quality Management System (QMS) for medical device and IVD products. The role keeps the QMS compliant with FDA's Quality Management System Regulation (21 CFR Part 820, aligned with ISO 13485:2016 since February 2026), ISO 13485, EU MDR/IVDR and MDSAP, and makes it scalable as the company grows.

This leader is the primary host for regulatory inspections and notified body audits, and partners with R&D, Operations, Regulatory Affairs and commercial teams to embed quality into every stage of the product lifecycle.

Key responsibilities

QMS ownership and strategy

• Responsible for maintaining compliance of the Quality Management System, Quality Manual and Document hierarchy; keeps it compliant with 21 CFR 820 (QMSR), ISO 13485:2016, ISO 14971, EU MDR/IVDR and MDSAP requirements.
• Works with VP/Head of Quality to build a multi-year QMS roadmap that scales with new products, sites and markets.
• Lead gap assessments when regulations or standards change, and drive remediation to closure.
• Select, implement and administer the electronic QMS (eQMS) and keep it validated (CSV/CSA, 21 CFR Part 11).

Core quality processes

• Own document and record control, training management, CAPA, nonconformance, deviations, internal audit and change control.
• Run the CAPA Review Board; ensure investigations use sound root-cause methods and effectiveness checks.
• Oversee complaint handling, MDR/vigilance reporting interfaces and post-market surveillance inputs to the QMS.
• Partner with Design Assurance on design controls, risk management files and design history files.

Audits and inspections

• Plan and execute the internal audit program; manage auditor qualification.