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Quality Assurance Specialist
hace 1 semana
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 PositionWe 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.