Biotechnology, Life Sciences, Genomics, Proteomics

Senior Manager, Quality Systems

Fremont, CAOnsiteFull TimeManager / Head$180,000–$200,000 /yrPosted 28 days agoVisa sponsorship available

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Required skills

21 CFR Part 820
ISO 13485:2016
ISO 14971
EU MDR/IVDR
MDSAP
CAPA
document control
training management
nonconformance
deviations

Nice to have

ASQ CQA
ASQ CQE
ASQ CMQ/OE
ISO 13485 Lead Auditor
IVD
diagnostics

Role summary

The Senior Manager, Quality Systems is responsible for the compliance and continuous improvement of the Quality Management System (QMS) for medical device and IVD products. This role ensures adherence to FDA regulations (21 CFR Part 820), ISO 13485, EU MDR/IVDR, and MDSAP. Key responsibilities include QMS strategy, ownership of core quality processes (CAPA, document control, audits), leading regulatory inspections and audits, and implementing/administering an eQMS. The position also involves managing the Quality Systems team, fostering a quality culture, and defining QMS KPIs. A Bachelor's degree in a technical field and 8+ years of quality experience in medical devices, with 4+ years in leadership, are required.

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.

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