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Quality Assurance Specialist

hace 1 semana


Valencia, Valencia, España Vitrolife Group A tiempo completo

About Vitrolife Group

Vitrolife Group is a leading global organization in the healthcare and genetic services industry. We are dedicated to unlocking the full potential of science and technology to reduce barriers towards building a family.

Our team at Vitrolife Group works every day to help our customers and their patients fulfill their dream of having a baby. We strive for excellence in our products and services, ensuring compliance with industry standards, regulations, and company policies.

Job Description:

Quality Assistant Position

We are seeking a detail-oriented and proactive Quality Assistant to join our Quality Assurance (QA) and Regulatory Affairs Department. The ideal candidate will play a vital role in maintaining and improving product and service quality.

Main Responsibilities:

  • Write, update, and maintain QA relevant documents, ensuring accessibility and proper storage.
  • Collaborate with other departments and affiliates to provide support/assistance in topics related to QA.
  • Ensure regular feedback and effective communications between the Laboratory Director, Top Management, and relevant stakeholders.
  • Follow deadlines to meet requirements on time.
  • Perform self-inspections/audits at appropriate regular intervals following a prearranged programme.
  • Coordinate and participate in external audits by External Bodies.
  • Report relevant changes that might impact quality certificates to competent bodies.
  • Identify, assess, log, and evaluate the effectiveness of incidents, NC & Complaints.
  • Participate and assist with product rollouts.
  • Stay informed about QARA updates with impact on the QMS (new/modified standards, local/international regulations, etc.) and analyze the impact.

Requirements:

  • Prior experience in a QA/QC role or related position in genetics, medical devices, in vitro diagnostics, Pharma, or similar environments.
  • Proficiency in quality management system software (e.g. Ipassport, others).
  • Knowledge of ISO15189 medical laboratories standards, CAP, CLIA, or related standards.
  • In-depth understanding of GLP requirements is a plus.
  • Bachelor's degree in Quality management/Engineering/Science or a similar field preferred.
  • Experience working in a Quality compliance function in Healthcare, Pharmaceutical, or Medical Device related industry (Genetics environment preferred).
  • Master's degree in quality management/quality assurance is a plus.

What We Offer:

  • An opportunity to work in a leading global organization in healthcare and genetic services.
  • A supportive and collaborative work environment.
  • Medical insurance.
  • Flexible compensation options.
  • Free coffee at the workplace.
  • Discounts on our platform and gym memberships.
  • Job stability in a growing and innovative company.

Salary:

$80,000 - $120,000 per year based on location and experience.