Develop, implement, and maintain the Quality Management System (QMS), including SOPs and document control.
Ensure compliance with 21 CFR Part 820 and applicable standards (e.g., ISO 13485, ISO 14971).
Establish and manage CAPA (Corrective and Preventive Action) processes.
Oversee complaint handling and evaluate reportability requirements.
Ensure design controls and software validation processes are in place and followed.
Conduct internal audits and prepare for FDA inspections.
Support risk management activities across the product lifecycle.
Train cross-functional teams on quality and compliance requirements.

Requirements

Bachelor's degree in Computer Science, Life Science, or Quality/Regulatory or equivalent combination of education and experience.
3–7 years of experience in medical device quality or a regulated industry.
Working knowledge of FDA Quality System Regulation (21 CFR Part 820).
Experience with QMS implementation, CAPA systems, and internal audits.
Familiarity with software development lifecycle (SDLC) and validation principles.
Preferred: Experience supporting FDA inspection or ISO audits.

Benefits

Comprehensive coverage starts first day of employment and includes Medical, Dental/Orthodontia, and Vision.
All Team Members are eligible for synthetic ownership in Experity upon one year of employment with real financial rewards when the company is successful!
Employee Assistance Program includes counseling, legal resolution, financial education, pet adoption assistance, identity theft and fraud resolution, and more.
Experity is committed to helping team members face the demands of juggling work, family and life-related issues by offering flexible work scheduling.
Experity offers a generous PTO plan that increases with milestones.
Experity maintains a learning program foundation for the company that allows Team Members to explore their potential and achieve their career goals.
We bring our Team Members together to strengthen the team, build relationships, and have fun!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Management System (QMS)SOPsdocument controlCAPA (Corrective and Preventive Action)design controlssoftware validationinternal auditsFDA inspectionsrisk managementsoftware development lifecycle (SDLC)

Soft Skills

trainingcross-functional collaboration

Certifications

Bachelor's degree in Computer ScienceBachelor's degree in Life ScienceBachelor's degree in Quality/Regulatory