layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Manager, Quality Systems at Alamar Biosciences

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.

Senior Manager, Quality Systems

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