Quality Assurance Specialist

Vitrolife Group•Miami, FL

About The Position

At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfill the dream of having a baby. Position Summary The Quality Assurance Specialist supports the development, maintenance, and continuous improvement of the Quality Management System (QMS) across designated Vitrolife Group laboratories. This role ensures alignment with accreditation requirements, regulatory standards, and internal quality expectations. It’s a strong fit for someone who is detail‑oriented, collaborative, and committed to high‑quality laboratory operations.

Requirements

Associate of Science or Associate of Arts required.
1+ year in Quality Compliance or Regulatory Affairs within Healthcare, Pharmaceuticals, Medical Devices, or related industry.
Fluent English
Strong analytical and problem‑solving abilities.
Excellent verbal and written communication skills.
Ability to multitask and work effectively under pressure.
High integrity, professionalism, and commitment to ethical work.
Strong collaboration skills and the ability to build trust across teams.

Nice To Haves

Bachelor’s degree in Quality Management, Engineering, Science, Business Administration, or related field preferred.
Experience in genetics or familiarity with Good Laboratory Practices (GLP) strongly preferred.
Working knowledge of ISO 15189, CAP, CLIA, and out‑of-state licensing processes is highly desirable.

Responsibilities

Participate in quality management meetings and provide ongoing feedback to QA leadership.
Prepare reports and contribute to Annual Management Review activities.
Support reporting of changes affecting certifications, licenses, or business operations.
Assist in analyzing KPIs, nonconformities, and customer complaints.
Track and monitor nonconformities and CAPA activities.
Support annual evaluations and monitoring of critical suppliers and referral laboratories.
Assist with new service launches or modifications to ensure regulatory and quality compliance.
Identify improvement opportunities across laboratory processes.
Participate in internal audits and support deviation investigations, root cause analysis, and corrective action follow‑up.
Manage nonconformity documentation during external audits.
Prepare responses and documentation requested by inspectors or auditors.
Promote a risk‑aware culture within assigned laboratories.
Coordinate risk assessments and maintain risk files.
Support development and delivery of training for laboratory and operational staff.
Maintain QMS document control and ensure alignment with applicable standards.
Implement document updates in collaboration with cross-functional teams.
Coordinate applications, renewals, and maintenance of laboratory certificates, permits, and licenses.