Lead, Quality, Compliance & Validation Strategy

Lumafield; Boston (MA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Cash and equity

Health stipend

401k

Parental leave

Flexible PTO

Commuter benefits

Company events

Job summary

Lumafield is seeking a seasoned Quality Leader to own the Quality Management System across design, hardware, software, metrology, field service, and lab operations. You will bridge cutting-edge tech with rigorous standards for medical devices and regulated industries.

Lead ISO 9001, ISO 13485, ISO 17025, 21 CFR Part 820, CSV, IQ/OQ/PQ initiatives, guide validation with customers, audits, and continuous improvement while partnering with engineering, product, and sales to drive compliant

Qualifications

• 10+ years of quality systems experience in technical or regulated environments.
• Deep expertise ISO 9001, ISO 17025, 21 CFR Part 11, CSV, IQ/OQ/PQ.
• Experience applying ISO 13485 and 21 CFR Part 820 to medical devices.

Responsibilities

• Own and unify the QMS across design, manufacturing, software, and services.
• Lead compliance programs to ISO 9001 and ISO/IEC 17025; prep for future certifications.
• Partner with engineering, product, and sales to guide regulatory requirements.
• Manage customer audits and regulatory inspections; support validation and submissions.
• Drive continuous improvement with data-driven risk mitigation.

Skills

Quality leadership

Regulatory compliance

Process improvement

Cross-functional

Six Sigma

Job description

Lumafield is seeking a seasoned Quality Leader to own the Quality Management System across design, hardware, software, metrology, field service, and lab operations. You will bridge cutting-edge tech with rigorous standards for medical devices and regulated industries.

Lead ISO 9001, ISO 13485, ISO 17025, 21 CFR Part 820, CSV, IQ/OQ/PQ initiatives, guide validation with customers, audits, and continuous improvement while partnering with engineering, product, and sales to drive compliant