Senior Quality Systems Manager – Regulatory & Compliance

Rti Surgical Inc; Florida; On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

PTO

401(k) match

Holiday pay

Medical/dental/vision

Disability coverage

Job summary

Evergen, a global CDMO in regenerative medicine, seeks a Quality Systems Manager to lead critical QMS programs in Alachua, FL. The role drives compliance with FDA and ISO standards, supports Notified Body audits, and guides document control, CAPA, and improvements across functions.

The position offers a strong leadership track, on-site duties in Alachua, competitive salary, and a comprehensive benefits package in a rapidly growing company focused on quality and patient safety.

Qualifications

• Bachelor’s degree in a life sciences discipline or related field.
• 5+ years of experience in a Quality or Regulatory Affairs role.
• 3+ years of leadership experience.
• 0-3 years of experience managing quality systems that require compliance with FDA Part 1271, FDA Part 820, ISO 13485 or AATB Standards.

Responsibilities

• Oversees critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives.
• Audits (internal and third-party) and leads Notified Body inspections support.
• Maintains quality registrations, licenses, accreditations, and certifications; manages CA/PA and notifications.
• Document management and record control; reviews and approves quality system documentation for accuracy.

Skills

QMS software

Communication

Excel

Process improvement

Data analysis

Education

Bachelor's in life sciences

Tools

Microsoft Office Suite

Job description

Evergen, a global CDMO in regenerative medicine, seeks a Quality Systems Manager to lead critical QMS programs in Alachua, FL. The role drives compliance with FDA and ISO standards, supports Notified Body audits, and guides document control, CAPA, and improvements across functions.

The position offers a strong leadership track, on-site duties in Alachua, competitive salary, and a comprehensive benefits package in a rapidly growing company focused on quality and patient safety.