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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