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Salary: USD 180,000 - 200,000 / annual
Alamar Biosciences is seeking a Senior Manager, Quality Systems to own the development, compliance, and continuous improvement of the company's Quality Management System (QMS) for medical device and IVD products. This role is critical to keeping the QMS compliant with FDA's Quality Management System Regulation (21 CFR Part 820), ISO 13485:2016, EU MDR/IVDR, and MDSAP standards, while ensuring scalability as the company grows.
The Senior Manager will serve as the primary host for regulatory inspections and notified body audits, partnering closely with R&D, Operations, Regulatory Affairs, and commercial teams to embed quality into every stage of the product lifecycle.
Key responsibilities include:
**QMS Ownership & Strategy:** Maintain compliance of the Quality Management System, Quality Manual, and document hierarchy across all applicable regulations. Work 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 change and drive remediation to closure. Select, implement, and administer the electronic QMS (eQMS) and maintain validation (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, ensuring investigations use sound root-cause methods and effectiveness checks. Oversee complaint handling, MDR/vigilance reporting, and post-market surveillance inputs. Partner with Design Assurance on design controls, risk management files, and design history files.
**Audits & Inspections:** Plan and execute the internal audit program and manage auditor qualification. Serve as delegate host and front-room lead for FDA inspections, notified body audits, MDSAP audits, and customer audits. Assist 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 & Metrics:** Run quarterly Management Review, compiling quality data, trends, and actions for executive leadership. Define and report QMS KPIs including CAPA aging, audit findings, training compliance, document cycle time, and 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.
**Requirements:**
- 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 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)
- Lead Auditor Training
