Quality Assurance Specialist II: Regulated QMS Expert

Geneoscopy; St. Louis (MO); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

401k with employer match

Paid time off

Company stock options

Job summary

Geneoscopy is seeking a Quality Assurance professional to ensure our products and services meet Quality Management System requirements. This hybrid role at our St.

Louis HQ involves maintaining regulatory compliance across CLIA, CAP, FDA, ISO, and other standards, while owning major QMS processes and supporting audits and records control. The role requires a Bachelor's degree and 3+ years in a regulated environment, with strong communication and team collaboration skills to drive continual

Qualifications

• Bachelor's degree required.
• 3+ years' experience in a CLIA/CAP or QSR/QMSR regulated environment.
• Ability to multitask and work in a fast-paced, deadline-driven environment.
• Strong verbal and written communication skills.

Responsibilities

• Assist in maintaining compliance with all applicable regulations and requirements (CLIA, CAP, NYS DOH, FDA, ISO, etc.).
• Own and manage one or more major processes under the Quality Management System.
• Support the QMS, including document and record control, nonconformances, customer complaint processes, training processes, audits, and other QMS work.
• Conduct gap analyses and best practice reviews to sustain and improve the QMS.
• Implement new/maintain procedures to achieve regulatory compliance and operational efficiency.
• Review records for accuracy.
• Coordinate quality processes.
• Participate in Management Review meetings.

Skills

Regulatory compliance

Quality management

multitask

Communication

Team collaboration

Education

Bachelor's degree

Job description

Geneoscopy is seeking a Quality Assurance professional to ensure our products and services meet Quality Management System requirements. This hybrid role at our St.

Louis HQ involves maintaining regulatory compliance across CLIA, CAP, FDA, ISO, and other standards, while owning major QMS processes and supporting audits and records control. The role requires a Bachelor's degree and 3+ years in a regulated environment, with strong communication and team collaboration skills to drive continual