Senior Manager, Quality Systems

The role

The Senior Manager, Quality Systems owns the compliance and continuous improvement of the company's Quality Management System for medical device and IVD products. This leader hosts regulatory inspections and partners with cross-functional teams to embed quality into the product lifecycle.

What you will do

• Maintain compliance of the Quality Management System, Quality Manual and Document hierarchy.
• Build a multi-year QMS roadmap with the VP/Head of Quality.
• Lead gap assessments and drive remediation to closure.
• Select, implement and administer the electronic QMS.
• Own document and record control, training management, CAPA, nonconformance, deviations, internal audit and change control.
• Run the CAPA Review Board.
• Oversee complaint handling, MDR/vigilance reporting interfaces and post-market surveillance inputs.
• Partner with Design Assurance on design controls, risk management files and design history files.
• Plan and execute the internal audit program.
• Serve as delegate host and front-room lead for FDA inspections, notified body, MDSAP and customer audits.

Required qualifications

• Bachelor's degree in engineering, life sciences or a related technical field.
• 8 + years in quality within medical device or IVD.
• 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.
• Experience 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 for audit-ready procedures and investigation reports.

Nice to have

• 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

Benefits

• bonus
• equity
• benefits

Before you apply

• We participate in E-Verify to confirm authorization to work in the United States.

About the company

Alamar develops innovative approaches to measure critical protein biomarkers from liquid samples. The team aims to enable the earliest possible detection of disease through highly multiplexed assays.