Medtech QMS Lead - Remote, ISO 13485 & FDA

Innolitics; Northern (KY); Hybrid; USD 100,000 - 120,000; Full time

Benefits offered by this job

Fully remote work

Flexible hours

Comprehensive PTO

401(k) plan with 3% match

Vision and dental plan

Annual company retreat

Job summary

Innolitics is a remote-first medical device consultancy hiring a Quality Assurance Specialist to lead Medtech OS implementations and ongoing quality services. The role focuses on QMS setup, policy creation, and ensuring compliance with ISO 13485 and FDA requirements.

Remote work with occasional client travel supports design controls, risk management, and audits. Ideal candidates have 3+ years in medical device QA, FDA inspection experience, and familiarity with Notion or similar eQMS platforms.

Qualifications

• 3+ years in medical device quality assurance or QMS implementations.
• Experience with at least one FDA inspection.
• Strong knowledge of ISO 13485 and FDA QMS requirements.
• Experience leading an eQMS implementation or major quality-system project.
• Regulatory submission experience not required; focus on QMS.

Responsibilities

• Lead Medtech OS implementations, scope QMS, plan and launch.
• Build and remediate quality systems with ISO 13485 alignment.
• Support design controls, risk management, and CAPA processes.
• Create audit-ready records: DMR, DDF, quality manuals and matrices.
• Train client teams and enable consistent QMS practices.
• Provide ongoing quality services including audits and reviews.
• Assess and remediate gaps, prioritize findings, close with evidence.
• Manage engagements, timelines, risks, and exec reporting.
• Improve Medtech OS through feedback and templating.
• Coordinate with regulatory for applicable QMS records.

Skills

QA/QMS implementation

FDA inspections

ISO 13485 knowledge

eQMS implementation

Notion platform

Quality documentation

Training clients

CAPA & audits

Education

ASQ certification

ISO 13485 auditor credential

Tools

Notion

eQMS platforms

Job description

Innolitics is a remote-first medical device consultancy hiring a Quality Assurance Specialist to lead Medtech OS implementations and ongoing quality services. The role focuses on QMS setup, policy creation, and ensuring compliance with ISO 13485 and FDA requirements.

Remote work with occasional client travel supports design controls, risk management, and audits. Ideal candidates have 3+ years in medical device QA, FDA inspection experience, and familiarity with Notion or similar eQMS platforms.