Alamar Biosciences
Senior Manager, Quality Systems
Fremont, California · Senior · Full-time
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
Level IV starts at $202,613 — $22,613 above the bottom of this range, and above its posted ceiling.
DOL prevailing wage, 2026-27 wage year · Industrial Production Managers (11-3051) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- 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.
- 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.
Responsibilities
- Responsible for maintaining compliance of the Quality Management System, Quality Manual and Document hierarchy
- 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).
- Own document and record control, training management, CAPA, nonconformance, deviations, internal audit and change control.
- Partner with Design Assurance on design controls, risk management files and design history files.
- 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.
- 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.
- Support supplier quality with audit scheduling, supplier qualification and Approved Supplier List controls.
Requirements
- Bachelor's degree in engineering, life sciences or a related technical field.
- Deep working knowledge of 21 CFR 820 (QMSR), ISO 13485:2016 and ISO 14971
- working knowledge of EU MDR/IVDR and MDSAP.
- Experience implementing or administering an eQMS (e.g., MasterControl, Greenlight Guru, Veeva, Arena, Qualio).
Nice to have
- ASQ CQA, CQE or CMQ/OE certification
- 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.
- Please Note - We participate in E-Verify to confirm authorization to work in the United States.
Skills
- clear, audit-ready procedures and investigation reports.
- Advanced degree (MS, MBA or PhD).
- 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.
- Your recruiter can share more about the specific salary range during the hiring process.
Compensation
- The base salary range for this full-time position is $180,000 - $200,000 + bonus + equity + benefits.
Company info
- At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients.
- Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.
This listing is sourced directly from Alamar Biosciences's careers page and normalized into a canonical job model.