Senior Manager, Quality Systems

Alamar Biosciences, Inc.; Fremont (CA); On-site; USD 180,000 - 200,000; Full time

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.

Skills

Quality systems

Regulatory compliance

Audits & inspections

CAPA

Documentation control

Leadership

Education

Bachelor's degree in engineering or life sciences

Advanced degree (MS, MBA or PhD)

ASQ CQA/CQE or CMQ/OE certification

ISO 13485 Lead Auditor certification

Tools

MasterControl

Greenlight Guru

Veeva

Arena

Qualio

Job description

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.
• Serve as delegate host and front-room lead for FDA inspections, notified body, MDSAP and customer audits.
• Assists with responses to FDA 483s, audit nonconformities and customer findings, with on-time closure.
• Support supplier quality with audit scheduling, supplier qualification and Approved Supplier List controls.

Management review and metrics

• Run quarterly Management Review; compile quality data, trends and actions for executive leadership.
• Define and report QMS KPIs (CAPA aging, audit findings, training compliance, document cycle time, complaint trends).

Leadership

• Hire, develop and lead the Quality Systems team; set goals and manage performance.
• Build a quality culture through cross-functional training and clear, practical procedures.
• Act as Management Representative or deputy when designated.

Required qualifications

• Bachelor's degree in engineering, life sciences or a related technical field.
• 8 + years in quality within medical device or IVD, including 4+ years leading teams and managers.
• Deep working knowledge of 21 CFR 820 (QMSR), ISO 13485:2016 and ISO 14971; working knowledge of EU MDR/IVDR and MDSAP.
• Direct experience hosting FDA inspections and notified body audits, and writing successful 483 or nonconformity responses.
• Hands‑on ownership of CAPA, document control, training, internal audit and management review processes.
• Experience implementing or administering an eQMS (e.g., MasterControl, Greenlight Guru, Veeva, Arena, Qualio).
• Strong writing skills: clear, audit‑ready procedures and investigation reports.

Preferred qualifications

• Advanced degree (MS, MBA or PhD).
• ASQ CQA, CQE or CMQ/OE certification; ISO 13485 Lead Auditor certification.
• IVD or diagnostics experience, including IVDR transition and MDSAP inspections.
• Experience scaling a QMS at a growth‑stage company through a first 510(k), De Novo or PMA and commercial launch.
• Familiarity with IEC 62304 (software), IEC 62366 (usability) and ISO 15223 (label symbols) where applicable.
• Lead Auditor Training

The base salary range for this full‑time position is $180,000 - $200,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job‑related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.

Please Note - We participate in E‑Verify to confirm authorization to work in the United States.

Voluntary Self‑Identification

For government reporting purposes, we ask candidates to respond to the below self‑identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Alamar Biosciences’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A \"recently separated veteran\" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.