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

Responsabilities

• Write, update, and maintain QA relevant documents, ensuring documents are accessible, properly stored and translated into the different languages needed.
• To 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.
• Following deadlines to meet requirements on time.
• Perform self-inspections/audits at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Coordinate and participate on external audits by External Bodies. Follow up and responses after external inspections. Deviation, CAPAS, and root cause analysis.
• Report (on-time) to competent bodies relevant changes that might impact quality certificates.
• Coordinate and participate of changes following up internal change control management procedures.
• Identify, assess, log and effectiveness evaluation of incident, NC & Complaints
• Participation and assistance with product rollouts.
• Stay informed about QARA updates with impact in the QMS (new/modified standards, new/modified local/international regulations, others), analyse impact and share information by participating in QARA regular meetings.

Experience

• Previous experience in a QA/QC role or related positionin genetics, medical devices, in vitro diagnostics, Pharma or similar environments would be valuable.
• Proficiency in quality management system software (e.g. Ipassport, others).
• Knowledge in ISO15189 medical laboratories 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 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 communications 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

Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalised genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of a fertility treatment.

We are currently approximately 1 100 colleagues worldwide, with headquarters in Gothenburg, Sweden. Vitrolife Group's products and services are available in more than 110 countries through our own presence in 30 countries and a network of distributors. Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF-clinics by providing superior products and services with the vision of fulfilling the dream of having a baby. The Vitrolife share is listed on Nasdaq Stockholm.