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Quality Control Lead (m/f/d)
Aktualität: 20.07.2021


20.07.2021, Abbott Rapid Diagnostics Jena GmbH
Quality Control Lead (m/f/d)
Promotes the awareness of regulatory and customer requirements throughout the organization Ensure compliance of test procedures, test records and sampling with regulatory requirements, in particular GMP, 21 CFR 820, DIN ISO 13458 and Medical Devices Act Development of and responsibility for specifications for raw materials, intermediate and end products Continuous improvement of test methods and processes in accordance with regulatory requirements and customer requirements along with relevant company divisions Ensuring timely qualification and calibration of all testing equipment used in quality control, as well as the integration of new testing equipment and processes in accordance with specifications Provision of on-going risk quality control assurance expertise and leadership to Project Core and Extended teams Ensuring embed Quality Control aspects in all stages of the design concept and feasibility to support R&D through specification setting, test development and provision of statistical sampling to ensure robust prototypes and design at design freeze Participating in technical reviews and risk management activities (FMEA) Quality Control support for audits including Abbott Corporate Audits and external Regulatory/Governing Body audits (e.g. FDA/WHO). Take the lead and front the team's participation in audits Manage a team of QC Engineers as the organization grows and develops Ability to work in a matrix organization where project deliverables are accountable to the Program/Workstream Leader
Primary Degree level qualification in Science, Engineering or Technology, plus 5+ years of Quality Control work experience within a regulated environment (ISO13485/FDA) Strong technical capability. Experience within an electronic or electrical environment and knowledge of NFC/Bluetooth would be an advantage Formal training in Medical Device Risk Management, Process Validation, Software Validation and Problem Solving would be beneficial Strong knowledge of statistical analysis Excellent data analysis skills Proven ability to work well as part of a team and on own Excellent communication skills to support virtual project requirements Clear demonstrated experience in working in a diverse cultural environment Excellent presentation skills to facilitate communication throughout the organization. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management. Very good German and English language skills (written and spoken) Travel pending company policy, global and country regulations to Asia and Europe.