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Senior QA Manager
role at
Vitrolife & Igenomix Brasil, part of Vitrolife Group.
Key Responsibilities
Understanding of product/service portfolio of the company.
Lead, coach, and develop the Vitrolife group QA team.
Maintain, improve and ensure compliance to the Quality Management System (QMS).
Implement quality standards across the Vitrolife Group of companies and support accreditation/certification processes.
Follow and adhere to QMS policies and procedures.
Monitor and evaluate internal processes.
Conduct root‑cause analysis and CAPA management.
Establish, implement, and supervise a programme of internal audits and participate in audits.
Analyze QMS KPIs.
Analyze customer feedback and incidents.
Evaluate product recalls when required.
Define, implement, review, and maintain validation plans and standards for software impacting quality and software as a medical device.
Oversee document control, ensuring documents are updated, properly stored, and legible.
Act as Management Representative for Top Management, reporting quality issues and annual reviews.
Act as main contact between the company and stakeholders, international accreditation bodies, notified bodies, etc.
Oversee medical device activities (classification reports, EUDAMED and AEMPS registration, sample collection kit documentation, communication with the Notified Body).
Drive and deliver quality‑related training and competence development.
Partner with leadership to strengthen the quality culture and continuous improvement mindset.
Collaborate with other sites and general QA functions to harmonize processes and share best practice.
Requirements
Earned a bachelor’s degree from an accredited institution.
Or earned a bachelor’s or master’s degree in Quality Assurance, Leading Auditor, or Compliance from an accredited institution.
Fluent English skills – other languages considered.
Previous experience in ISO 15189, CAP, CLIA, ISO 9001 checklist and inspections.
Medical devices in vitro diagnosis experience is a strong advantage (ISO 13485).
Why Vitrolife Group
Purpose‑driven work that helps people fulfill their dream of having a healthy baby.
Continuous learning and professional growth opportunities.
Global collaboration in a multicultural, inclusive environment.
Strong foundation of quality, integrity, innovation, and collaboration.
What We Offer
Opportunity to work in a leading global organization in healthcare and genetic services.
Supportive and collaborative work environment.
Training opportunities for candidates without direct experience in some areas.
Medical insurance.
Flexible compensation options.
Free coffee at the workplace.
Flexitime.
Discounts on our platform and gym memberships.
Job stability in a growing and innovative company.
Interview conducted in English.
Employee based in Valencia (Parque tecnológico de Paterna).
Department : Quality & Regulatory
Location : Valencia (Remote Hybrid)
Employment type : Full‑time
Seniority level : Mid‑Senior
Job function : Quality Assurance
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