AddressPurpose of the Job :
- Identify existing deviations, take corrective actions and prevent recurrence.
- Take pro-active actions to Quality Assurance aspects.
- Drive improvement projects.
Requirements:
Education : Degree in Engineering or Software (e.g. mechanical engineering, electrical engineering, industrial engineering)
Work Experience :
- Minimum 5 years of professional experience, preferably in the Medical Device industry
- Experience in Quality Assurance, Regulatory Affairs, Software Development
- Experience in applying Quality methods and tools
- Preferably experience in working with agile methods
- Preferably experience in working with digital solutions, e. g. workflow based CAPA process.
Specific Knowledge/Skills :
- Expertise in national and international Medical Device standards and regulations, Regulation (EU) 2017/745, ISO 13485:2016, MDSAP, MPDG, Directive 93/42/EEC, etc.
- Communication skills
- Problem solving skills
- Decision making skills
- Analytical skills
- Project Management
- Data-driven decision-making
- Trainer skills
- At minimum fluent in English.
- Knowledge of German is an advantage.
Main tasks:
- Planning, inspection and reporting of Deviations and Supplier relevant topics to identify possible hazards and recommend corrective and preventive actions.
- Pro-actively manage Non-Conformity and CAPA processes and determine root causes.
- Ensure timely and risk-appropriate processing.
- Oversee complaint management activities and address incidents as required.
- Drive the process of Supplier Qualification and approval.
- Evaluate, create and negotiate Quality Assurance Agreements (QAA)
- Initiate and participate in regular team meetings with other team members with focus on Quality Assurance, e. g. Deviations.
- Conducting training sessions for all employees to ensure that they understand how to perform their job to assure safety, performance, and efficiency.
- Writing, reviewing and approving Work Instructions or other relevant documents to assure QA aspects are being followed.
- Monitoring processes regarding compliance to applicable regulatory requirements, e. g. outsourced production or services
- Reviewing data from customers to identify potential problems with products or services and suggest improvements.
- Monitoring and reporting of processes based on objective Performance Indicators.
- Expert in data-driven processes, transfer from static manually available data in automatization to drive better decisions based on real-world data.
- Identify business risks from compliance aspects in the field of responsibility in implementation before they become a problem.
Risk Monitoring:
- Initiation, planning and reviewing project objectives, timelines, and budgets to ensure that they are realistic and achievable.
- Initiate Vigilance process and as required support Field Safety Corrective Actions, recalls, etc.
- Initiation, monitoring, and follow-up on information about regulatory compliance.
- Responsible for conducting internal and support external audits in the field of responsibility.
