Head of Quality, Compliance & Validation Strategy

Lumafield; Boston (MA); Sur place; USD 150 000 - 210 000; Plein temps

Avantages offerts par ce poste

Cash + equity

Health stipend

401k

Parental leave

Flexible PTO

Commuter benefits

Company events

Résumé du poste

Lumafield is seeking an experienced Quality Leader to own and scale the Quality Management System across design, hardware manufacturing, software, cloud services, metrology, and lab operations. You will lead compliance against ISO 9001, ISO 13485, ISO 17025, and 21 CFR Part 820, guiding validation and customer audits with enterprise clients.

You’ll partner with product, engineering, and customer success to deliver validated solutions, drive continuous improvement, and ensure regulatory readiness

Qualifications

• 10+ years of quality leadership experience in highly regulated environments, preferably medical devices.
• Deep hands-on experience implementing ISO 9001, ISO 17025, and 21 CFR Part 11 and CSV.
• Ability to adapt quality systems to customer requirements across multiple sectors (Medical, Automotive, Aerospace, Defense).
• Strategic thinker balancing rigorous processes with startup agility.
• Strong communication skills translating complex quality needs to engineers and customers.

Responsabilités

• Own the QMS across design, development, manufacturing, software, cloud services, metrology, field service, and customer applications.
• Lead compliance initiatives for ISO 9001 and ISO/IEC 17025; prepare for future certifications as the business scales.
• Collaborate with enterprise customers to demonstrate system robustness and provide validation documentation.
• Advise Product and Engineering to deliver fully validated solutions for regulated industries.
• Manage external and internal audits as primary liaison with customers and regulators.
• Partner with engineering, product, customer success, and sales on regulatory requirements and QA best practices.
• Drive continuous improvement using data-driven insights to reduce risks and improve processes.

Connaissances

QMS Design

ISO 9001

ISO 17025

21 CFR Part 11

CSV

IQ/OQ/PQ

Regulatory Auditing

Cross-functional leadership

Quality Metrics

Customer Validation

Outils

QMS software

Description du poste

Lumafield is seeking an experienced Quality Leader to own and scale the Quality Management System across design, hardware manufacturing, software, cloud services, metrology, and lab operations. You will lead compliance against ISO 9001, ISO 13485, ISO 17025, and 21 CFR Part 820, guiding validation and customer audits with enterprise clients.

You’ll partner with product, engineering, and customer success to deliver validated solutions, drive continuous improvement, and ensure regulatory readiness