Supplier Quality Auditor - Regulatory Affairs - Medical Devices Industry

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.