Quality Assurance

hace 2 días

Paterna, España Igenomix A tiempo completo

Career Opportunity at Igenomix: Internal Vacancy: Quality Assurance & Regulatory Affairs Assistant

**Exciting opportunity within Igenomix - Pioneers in advanced reproductive genetic testing.**

At IGENOMIX we provide advanced services in reproductive genetics. Our broad experience and qualifications make us the global leader in this field. The constant efforts we make in R&D, enable us to create and develop specific tools to support professionals in the reproductive medicine area.

Igenomix is part of Vitrolife Group, Vitrolife is an international medical device and genetic services Group. Vitrolife develops, produces and markets products for reproductive health together with services that provide personalised genetic information to improve clinical practices in infertility, women’s health and rare diseases. Headquartered in Gothenburg, Sweden, the Group currently employs approximately 1,200 people worldwide. Its products, services and solutions are available in more than 110 markets through a network of subsidiaries and distributors. The Group has wide-ranging experience in the fertility field with an advanced research capacity. The Vitrolife share is listed on NASDAQ Stockholm.

We are offering one outstanding opportunity to join our team in a temporary position as Quality Assurance & Regulatory Affairs Assistant based in Paterna (Valencia), Spain.

**What are you accountable for achieving?**
- Manage the documents life-cycle including, but not limited to, reviewing and revising documentation, assigning skilled groups and routing documents for approval and qualification.
- Manage Post-Market Surveillance (PMS) activities including PMS plans and reports per each of the products.
- Monthly incidents & complaints analysis.
- Support to the RA Team in maintaining the IFUs of the products to ensure compliance with relevant international standards and regulatory requirements.
- Work closely with the QARA Team of other laboratories worldwide within the business genetics services area.

**Desirable requirements**:

- At least 1-2 years experience in Quality Assurance or Regulatory related role (health care/ clinical laboratories field will be positively valued).
- Familiar with and understands Quality and Regulatory standards such as ISO15189, CE Mark, ISO 13485 standars and IVDR framework.
- Outgoing person with excellent communication skills.
- Commitment, proactivity, organization, used to work to commit deadlines and ability to work as a team.
- Must be multi-task person and result-driven.
- Fluent English skills - High Level (B2) other languages are a plus.
- Skilled in MS Office (Excel, Power point, Word) tools.
- Skilled/experience in Sharepoint and Ipassport (desirable).

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