CAPA/CAPA Specialist

Job Description:

Purpose 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.

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.