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.

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 follow‑up.

External Audit Support

• Manage nonconformity documentation during external audits.

• Prepare responses and documentation requested by inspectors or auditors.

Risk Management

• Promote a risk‑aware 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 cross‑functional 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 out‑of‑state licensing processes is highly desirable.

Skills & Competencies

• 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.

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

• 401(k) plan with company safe harbor matching

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.