Quality Assistant

hace 1 semana


Valencia, 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.

We are seeking a detail-oriented and proactive Quality Assistant to join our Quality Assurance (QA) and Regulatory Affairs Department. The Quality Assistant will play a vital role in maintaining and improving product and service quality, ensuring compliance with industry standards, regulations, and company policies.

*We follow a hybrid work model, with four days in the office and one day working from home each week.

Responsibilities
  • Write, update, and maintain QA relevant documents, ensuring documents are accessible, properly stored, and translated into the different languages needed.
  • 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 and ensure necessary corrective measures are put in place.
  • Coordinate and participate in external audits by External Bodies. Follow up and respond after external inspections. Address deviations, CAPAs, and root cause analysis.
  • Report (on-time) to competent bodies relevant changes that might impact quality certificates.
  • Coordinate and participate in changes following internal change control management procedures.
  • Identify, assess, log, and evaluate the effectiveness of incidents, NC & Complaints.
  • Participate in and assist with product rollouts.
  • Stay informed about QARA updates impacting the QMS (new/modified standards, new/modified local/international regulations, etc.), analyze the impact, and share information by participating in QARA regular meetings.
Experience
  • Previous experience in a QA/QC role or related position in genetics, medical devices, in vitro diagnostics, Pharma, or similar environments would be valuable.
  • Proficiency in quality management system software (e.g., Ipassport, others).
  • Knowledge of ISO15189 medical laboratory standards, CAP, CLIA, or related standards.
  • In-depth understanding of GLP requirements is a plus.
Education
  • Bachelor's degree in Quality Management/Engineering/Science or a similar field preferred.
  • Experience working in a Quality compliance function in the Healthcare, Pharmaceutical, or Medical Device related industry (Genetics environment preferred).
  • Master’s degree in Quality Management/Quality Assurance is a plus.
Competencies and Skills
  • Excellent verbal and written communication skills.
  • Strong attention to detail.
  • Thrives in a collaborative environment; strong team player.
  • Ability to work under pressure and manage multiple priorities.
  • Adaptability to evolving processes and requirements.
  • Advanced English language skills, including the ability to write clear, concise documentation and communicate effectively with team members and stakeholders.
  • Basic understanding of quality assurance and quality control principles.
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.
  • Discounts on our platform and gym memberships.
  • Job stability in a growing and innovative company.

*The interview will be conducted in English.

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