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Senior QA Manager
hace 2 semanas
_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._ _
- 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._**Main Purpose**
To champion a culture of quality and continuous improvement across the Vitrolife Group, ensuring that all products and services consistently meet the highest regulatory standards and contribute to excellent patient outcomes. As a key strategic partner to Top Management, the Quality Manager plays a central role in shaping, maintaining and advancing a robust and harmonized Quality Management System (QMS) that aligns with global best practices, reinforces compliance, and supports innovation and operational excellence across all affiliates.
**Key Responsibilities**
The Quality Manager oversees the QMS in the Genetic Services offices and acts as a consultant to the affiliates across the Vitrolife Group. Key responsibilities include:
- 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)
- Implementing Quality Standards across the Vitrolife Group of companies and supporting them in their accreditation/certification processes.
- Following and adhering to the QMS policies and procedures.
- Monitoring and evaluating internal processes.
- Root-cause analysis and CAPA management.
- Establish, implement, and supervise a programme of internal audits and participate in internal audits.
- Data analysis and tend analysis of QMS KPIs.
- Analysis of customer feedback and incidences.
- Evaluating product recalls (when required/needed).
- Define, implement, review and maintain validation plans and standards for software with impact in the Quality and software as medical device.
- Oversee the document control, ensuring documents are updated on a regular basis, properly stored and legible.
- Act as Management Representative for Top Management and reporting to Top Management on quality standard issues and annual management reviews.
- Act as main contact between the company and the stakeholders, international accreditation bodies, notified bodies, others.
- Oversee medical devices activities (classification reports, EUDAMED and AEMPS registration, sample collection kit documentation, communications with the Notified Body and others)
- Drive and deliver quality related training and competence development
- Partner with leadership to strengthen our quality culture and continuous improvement mindset
- Collaborate with other sites and global QA functions to harmonize processes and share best practice.
**Requeriments**
- Have earned a bacherlor´s degree from an accredited institution.
- Or have earned a bacherlor´s degree or master degree in Quality assurance/leading auditor or compliance from an accredited institution.
- Fluent English skills - other languages would be 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?**
Because here, your work truly matters. You’ll be joining a team where:
- Meets purpose, and every project is guided by the desire to help more people fulfill their dream of having a healthy baby.
- Learning never stops, and you’ll have opportunities to grow professionally while contributing to a meaningful mission.
- Global collaboration is part of our DNA. You’ll work with colleagues across countries in a multicultural, inclusive environment.
- Quality, integrity, innovation and collaboration are not just words, they’re the foundation of how we work and grow together.
**What we offer**
- Opportunity to work in a leading global organization in healthcare and genetic services.
- Supportive and collaborative work environment.
- 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.
The interview will be conducted in English
The employee will be based in Valencia (Parque tecnológico de Paterna).
- 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 supe
