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QUALIFICATIONS AND JOB DESCRIPTION
JOB DESCRIPTION
- The primary purpose of this position is to develop, establish and maintain quality assurance system, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards.
- Management Representative & Regulatory Compliance Responsible for BMT Calsis, BMT Baps, Burgeon, Set Biyoteknoloji and BMT Biomaterial GmbH companies.
- The following big projects for the candidate would be the MDR certification of group products and additionally some other major international medical device certifications such as FDA, ANVISA, etc.
Key duties and responsibilities:
- Description of the main responsibilities. Can be divided into several headlines.
- Represent executive management in terms of the Quality Management System.
- Represent local management during external audits and inspections.
- Develop, define, maintain and revise processes, and QMS procedures to ensure company and products comply with applicable regulations and laws.
- Develop and monitor quality objectives in the area of quality assurance and quality management activities.
- Measure and monitor the performance of the processes, analyze and report the quality performance measurements to top management.
- Ensure effective document control & records control processes are developed and maintained.
- Organize and prepare management review meetings and report the performance of the QMS to local Executive Management.
- Prepare audit schedules, execute internal audits and evaluate audit reports.
- Identify and direct continuous improvement projects and CAPAs. Ensure adequate followup through the implementation of corrective and preventive actions as appropriate.
- Manager the day to day operations of the QA function to achieve Quality Objectives and targets
- Ensure sufficient supplier controls are in place to secure product safety and conformity to specified requirements.
- Ensure by review/ approval process that necessary validations are performed on equipment, processes and software used in manufacturing and product testing
- Ensure independent final release of products
- Local support in the quality area
- Ensure that the company follows national and international laws and requirements regarding export of products and services.
- Approve non-conformance reports if they are accepted with deviations
- Approve impact analyses for equipment found out of calibration
Compliance
- Ensure the manufacturing facility has implemented a quality system fully compliant to ISO 13485 and/or FDA's QSR Part 820, and any additional applicable regulations.
- Ensure the Quality Policy and Quality Manual are implemented and communicated at all levels of the organization
- Ensure implementation of the quality plans to minimize compliance and business risks.
- Review computerized system validation for GxP systems
Regulatory Affairs and Product Compliance
- Manage Regulatory Affairs issues with authorities
- Apply for and maintain product approvals according to Market Introduction Plan (MIP), e.g. 510(k) and/or technical file CE marking.
- Ensure compliance with all applicable regulations for the product portfolio.
- Review and approve product documentation including marketing material.
- Participate in risk assessments for products
- Assess product changes for regulatory impact.
Quality System Duties and Responsibilities:
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Essential Functions
- To ensure that all Quality Assurance and Quality Control activities are established and maintained including, product release, review of non-conforming products, discrepancy investigations, resource allocation, product and process validation, test and inspection methods, contract review and internal auditing programs
- To report to Top Management the perfomance of the company's Quality System and manage its continual improvement
- To manage all Regulatory Compliance activities including, complaint handling, Medical Device Reporting and communication with the relevant regulatory agencies
- To manage the Quality Assurance personnel and associated budgets
- To provide information on the Quality requirements for all Design projects and participate to Design Reviews
- To complete the duties about this Job delivered by the Managing Director on time and in full
- To take maximum precautions to save money
- Compliance with occupational health and safety law no. 6331
- To comply with the Social Insurance and General Health Insurance Law No.5510 and to comply with the rules determined by the company
REQUIRED QUALIFICATIONS
- Bachelor's degree in science or engineering.
- Minimum 3 years related experience in QA in a Medical Device manufacturing environment.
- Previous background and experience in Quality Assurance and Manufacturing.
- Strong knowledge and experience in MDR (European Medical Device Regulation), 21 CFR part 820, ISO 13485, 93/42/EEC, 2017/745/EU and other related regulatory requirements.
- A demonstrated knowledge and understanding of international medical device quality system requirements (such as, FDA QSR, ISO 13485, MDD, MDSAP, China GMP, ANVISA)
- Successful interactions and experience with regulatory agencies.
- Experience writing technical documents; Clinical Evaluation reports a plus
- Strong Supplier Quality and Process Validation Skills (IQ, OQ, PQ, PVE) and Experience essential to success in this role
- Good knowledge of statistics and practical application of the QSR and ISO 13485.
- Good knowledge of Microsoft Office programs
- Good command of English
- Self motivated and responsible
- Have leadership attributes
- Analytical thinking, high communication skills
- Excellent interpersonal and listening skills.
- Able to interact with all levels of the organization in providing direction or information
- Strong researcher and problem-solving ability
- Having a good level of knowledge about the sector
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