Conduct Incoming Inspection, QC, and in-process control activities per procedure and product requirements.
Support product/Batch release.
Write, review, and approve procedures and work instructions.
Provide support in the maintenance and improvement of the QMS.
Participate in product quality investigations in support of CAPA and Nonconforming material processes.
Support continuous improvement activities to reduce product failure rates.
Reviewing data and conducting statistical analysis
Collaborate with other departments and CMs functions to ensure high-level quality standards.
Performing Internal and External Audits
Represent Quality in a core team of different projects.
Supporting activities required to ensure Subcontractors and Suppliers compliance with Companys requirements.
Evaluating and supporting Suppliers and subcontractors quality performance
Take an active role in reviewing
Requirements: Bachelors Degree in Life Science, Biology/Biomedical science/Biotechnology/ Biomedical engineering
Proven experience in Quality systems (minimum 5 years) and in multidisciplinary medical device company (minimum of 2-3 years).
Certification for conducting Internal and External Audits per ISO-13485, including proven experience.
Experience in conducting investigations according to root Cause Analysis methodologies (familiarity with 5Y and fishbone methods).
Experience working in an FDA and ISO 13485 regulated environment.
Strong understanding of QMS requirements and improvement activities, and processes.
Ability to analyze data and conduct statistical KPIs.
Analytical skills, problem-solving, and strong communication skills, both verbal and in writing, are required.
Project Management skills and Leadership without direct authority responsibility.
Self-motivated and proactive approach, abil
This position is open to all candidates.
