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.