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Quality Assurance SpecialistVitrolife Group • United States
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Quality Assurance Specialist

Vitrolife Group
  • US
    United States
  • US
    United States
Apply Now

About

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.
Location: Onsite in Miami, FL
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 detailoriented, collaborative, and committed to highquality laboratory operations.
Key Responsibilities
Quality Management & Reporting
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. KPI, Incident, and Compliance Monitoring
Assist in analyzing KPIs, nonconformities, and customer complaints. Track and monitor nonconformities and CAPA activities. Supplier & Referral Lab Oversight
Support annual evaluations and monitoring of critical suppliers and referral laboratories. Service Launch & Change Management
Assist with new service launches or modifications to ensure regulatory and quality compliance. Continuous Improvement, Internal Audits & CAPA
Identify improvement opportunities across laboratory processes. Participate in internal audits and support deviation investigations, root cause analysis, and corrective action followup. External Audit Support
Manage nonconformity documentation during external audits. Prepare responses and documentation requested by inspectors or auditors. Risk Management
Promote a riskaware culture within assigned laboratories. Coordinate risk assessments and maintain risk files. Training & QMS Documentation
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 crossfunctional teams. Certification & Licensing
Coordinate applications, renewals, and maintenance of laboratory certificates, permits, and licenses. Qualifications
Education
Associate of Science or Associate of Arts required. Bachelor's degree in Quality Management, Engineering, Science, Business Administration, or related field preferred. Experience
1+ year in Quality Compliance or Regulatory Affairs within Healthcare, Pharmaceuticals, Medical Devices, or related industry. Experience in genetics or familiarity with Good Laboratory Practices (GLP) strongly preferred. Working knowledge of ISO 15189, CAP, CLIA, and outofstate licensing processes is highly desirable. Skills & Competencies
Fluent English Strong analytical and problemsolving 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. Benefits
Paid Time Off and 10 Paid Holidays 401(k) with Employer Match Medical, Dental, Vision IVF Coverage to support family building needs GAP Insurance Basic Life and AD&D Coverage Short- and Long-Term Disability Optional AFLAC Supplemental Policies Employee Assistance Program (EAP) Flexible Spending & Health Savings Account
An offer of employment is contingent on the successful passing of a background check.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of fertility treatment.
We are currently approximately 1 100 colleagues worldwide, with headquarters in Gothenburg, Sweden. Vitrolife Group's products and services are available in more than 110 countries through our own presence in 30 countries and a network of distributors. Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF-clinics by providing superior products and services with the vision of fulfilling the dream of having a baby. The Vitrolife share is listed on Nasdaq Stockholm.
Department QA/QC Locations Miami Employment type Full-time
  • United States

Languages

  • English
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