CAPA/CAPA Specialist
1 Nos.
92058
Full Time
4.0 Year(s) To 8.0 Year(s)
9.00 LPA TO 13.00 LPA
IT Software - Middleware
IT-Software/Software Services
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.
Company Profile
internationally leading technology enterprise operating in the fields of optics and optoelectronics. In the previous fiscal year, the Group generated annual revenue totaling 8.8 billion euros in its four segments Semiconductor Manufacturing Technology, Industrial Quality & Research, Medical Technology and Consumer Markets
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