Kalite Güvence Sorumlusu

Betatech Medikal Cihazlar San.Müm.İç ve Dış Tic.Ltd

As a major independent player in the design, research, production and sale of surgical products as surgical sutures, hernia mesh, absorbable hemostats, synthetic bone graft, adhesion barrier gel, bone cement, neurosurgical patties and hyaluronic acid cystitis solution.

We are looking for a Quality Assurance Specialist!

Qualifications:

- Bachelor's degree in a relevant field (e.g., engineering, biology, chemistry).

- 3-5 years of experience in Quality Management Systems.

- Knowledge of ISO 13485 and MDD 93/42/EEC, preferably MDR 2017/745, global regulatory requirements for medical devices, preferably MDSAP and FDA 21 CFR Part 820 regulations

- Strong understanding of regulatory submission processes and documentation.

- Good command of the English language.

- Ability to use MS Office programs effectively.

- Excellent communication skills, both written and verbal.

Job Description:

- Actively participate in the implementation and maintenance of Quality Management Systems, aligning with ISO 13485, MSDAP, and FDA 21 CFR Part 820 regulations.

- Support technical file documentation as clinical evaluation, risk analysis, biological evaluation and PMCF.

- Assist in conducting both internal and external audits, contributing to the evaluation of compliance with quality standards and regulatory requirements.

- Provide assistance in utilizing risk management tools, including Failure Mode and Effects Analysis (FMEA), to contribute to the enhancement of product safety.

- Collaborate with cross-functional teams, including manufacturing, research and development, and regulatory affairs, engaging in collaborative efforts and learning opportunities.

- Monitor supplier quality certificates and participate in supplier evaluations under guidance.

- Contribute to the oversight of change management and control processes, ensuring the effective implementation of changes in compliance with regulatory standards.

- Participate in cross-functional team efforts to evaluate and document the impact of proposed changes on quality systems and products.

- Collaborate with cross-functional teams to contribute to the establishment of validation master plans and ensure alignment with regulatory requirements.

- Contribute to continuous improvement initiatives aimed at enhancing overall product quality and operational efficiency.

- Assist in revalidation activities and contribute to continuous improvement initiatives based on validation findings.

- Participate in monitoring and assessing revisions to international standards and regulations, supporting proactive adaptation and compliance efforts.

- Support the planning, implementation, and improvement of Quality Assurance processes.

- Contribute to monitoring and reporting on the risks, objectives, and needs of Quality Assurance processes.

- Provide assistance in the management and reporting of internal audits.

- Assist in following up on negative incidents related to product quality and contribute to the solution processes.