Quality Assurance

hace 4 meses

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).

  • Quality Assurance Systems Leader

    hace 2 semanas

    Paterna, Valencia, España Albelli A tiempo completo

    Overview of the Position As a Quality Assurance Systems Leader at Albelli Photobox Group, you will be instrumental in nurturing a culture centered on continuous enhancement and a steadfast commitment to quality and occupational health & safety (OH&S) across our diverse manufacturing locations. Collaborating within the Industrial Engineering & Planning...

  • Quality Assurance Systems Leader

    hace 2 meses

    Paterna, Valencia, España Albelli A tiempo completo

    Overview of the Position As a Quality Assurance Systems Leader at Albelli Photobox Group, you will be instrumental in nurturing a culture centered on continuous enhancement and a steadfast commitment to quality and occupational health & safety (OH&S) across our diverse manufacturing locations. Collaborating within the Industrial Engineering & Planning...

  • Quality Assurance Specialist

    hace 1 mes

    Paterna, Valencia, España ZimVie US Corp A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at ZimVie US Corp. As a key member of our quality team, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesGuarantee quality compliance of processes and products associated with suppliers.Ensure that products are...

  • Quality Engineer

    hace 4 meses

    Paterna, España ZimVie A tiempo completo

    Welcome to ZimVie, a publicly traded global company focused on restoring daily life to our patients. Our company is founded on a legacy of established brands, medical experts and over $900M in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery, and bone growth...

  • Quality Engineer

    hace 4 meses

    Paterna, España ZimVie A tiempo completo

    Welcome to ZimVie, a publicly traded global company focused on restoring daily life to our patients. Our company is founded on a legacy of established brands, medical experts and over $900M in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery, and bone growth...

  • Quality Systems Manager

    hace 4 días

    Paterna, Valencia, España Albelli A tiempo completo

    About the RoleAs a Quality Systems Manager at Albelli, you will play a pivotal role in driving a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with local quality...

  • Quality Systems Manager

    hace 4 días

    Paterna, Valencia, España Albelli A tiempo completo

    About the RoleAs a Quality Systems Manager at Albelli, you will play a pivotal role in driving a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with local quality...

  • Quality Systems Manager

    hace 3 semanas

    Paterna, Valencia, España Albelli A tiempo completo

    About the RoleAs a Quality Systems Manager at Albelli, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with local quality...

  • Quality Systems Manager

    hace 3 semanas

    Paterna, Valencia, España Albelli A tiempo completo

    About the RoleAs a Quality Systems Manager at Albelli, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with local quality...

  • Quality Systems Manager

    hace 5 meses

    Paterna, España Albelli A tiempo completo

    About the role As a Quality Systems Manager at Albelli Photobox Group, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely...

  • Quality Engineer

    hace 4 meses

    Paterna, España ZimVie US Corp LLC A tiempo completo

    We are **ZimVie**, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients’ smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team...

  • Quality Systems Manager

    hace 4 meses

    Paterna, España Albelli-Photobox Group A tiempo completo

    **About the role** As a Quality Systems Manager at Albelli Photobox Group, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely...

  • Quality Systems Manager

    hace 1 mes

    Paterna, Valencia, España Albelli A tiempo completo

    About the RoleAs a Quality Systems Manager at Albelli, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with local quality...

  • Quality Systems Manager

    hace 1 mes

    Paterna, Valencia, España Albelli A tiempo completo

    About the RoleAs a Quality Systems Manager at Albelli, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with local quality...

  • Genetics Research and Development Specialist

    hace 4 semanas

    Paterna, Valencia, España Vitrolife Group A tiempo completo

    About the RoleWe are seeking an exceptional Carrier & Infertility Genetics R&D Specialist to join our team at the Vitrolife Group in Valencia, Spain.Key ResponsibilitiesAnalyze clinical data to validate Next Generation Sequencing tests and provide oversight for quality control and quality assurance.Interpret variants using public and professional tools,...

  • Genetics Research and Development Specialist

    hace 4 semanas

    Paterna, Valencia, España Vitrolife Group A tiempo completo

    About the RoleWe are seeking an exceptional Carrier & Infertility Genetics R&D Specialist to join our team at the Vitrolife Group in Valencia, Spain.Key ResponsibilitiesAnalyze clinical data to validate Next Generation Sequencing tests and provide oversight for quality control and quality assurance.Interpret variants using public and professional tools,...

  • Laboratory Technician

    hace 2 días

    Paterna, España Vitrolife Group A tiempo completo

    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.The job involves working flexible/swing shifts. The candidate would be expected to be part of a rotation in nights, weekends,...

  • Laboratory Technician

    hace 3 semanas

    Paterna, España Vitrolife Group A tiempo completo

    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._ **Experience**: - Laboratory science degree, or medical laboratory technology from an accredited institution (_Ciclos...

  • Regional Sales

    hace 4 meses

    Paterna, España Igenomix A tiempo completo

    **Regional Sales & Marketing Coordinator responsible for Southwest Europe, Africa and Israel** Exciting opportunity with 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...