.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