Principal Duties & Responsibilities

• To oversee testing and validation processes, as necessary, including protocol and report development, to ensure compliance with quality standards
• Monitoring and analyzing quality metrics and performance indicators to identify trends, areas for improvement, and opportunities for process optimization
• Conducting or participating in risk management activities and implementing risk management strategies to identify and mitigate potential quality issues for new and existing products and processes
• To review Change Requests and assess quality impact of product and process changes
• Proactively driving activities to meet and/or exceed company objectives
• Collaborating with cross-functional teams, including Value Stream, Manufacturing, and Regulatory Affairs, to ensure quality considerations are integrated into new product development/transfers, and manufacturing processes
• To lead or participate in internal and external audits to assess compliance with quality standards and regulatory requirements.
• Using appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making May act as project lead for functional and cross-functional projects, including generation of the project definition, plan, and requirements
• Promoting a culture of continuous improvement within the department and the broader company
• Performing other related duties and responsibilities as assigned
• To give contribution to the definition and implementation of QS relevant projects and also to the definition and implementation of QS relevant software support

Your Profile

• Bachelor’s degree in a scientific /engineering or related field
• Minimum of 5 years of experience in medical device industry
• Strong understanding of quality management systems, regulatory requirements, and industry standards specific to medical devices, including a working knowledge of 21 CFR 820, EUMDR, ISO 13485:2016, ISO 14971:2019 and MDSAP

• Strong understanding of the product development process
• Knowledge of injection molding, automation and extrusion process
• Extensive experience with root cause analysis, validation and statistical data analysis
• Demonstrated ability to manage and prioritize assigned project tasks to deliver on-time, on-quality, and on-budget
• Demonstrated ability in the development and execution of detailed validation test protocols.
• Experience with process, sterilization and packaging validation activities preferred.
• Excellent leadership, communication, and problem-solving skills to effectively manage a team and drive continuous improvement in quality processes and outcomes
• Detail-oriented with strong organizational and project management skills
• Strong attention to detail and ability to work in a fast-paced environment
• Demonstrated ability to collaborate effectively with cross-functional team members
• Minitab experience preferred.
• Six Sigma/Lean experience preferred
• Good IT knowledge (e.g. MS Office applications, SAP, MS Sharepoint, Lotus Notes, Trackwise, etc.)
• Having good command of English skill, proficiency in another language will be a plus,
• Living in Antalya or willing to relocate,
• No military obligation for male candidates.