Process Validation & Quality System Expert – Veszprém

Responsibilities:

Process- and Software Validation (Process Owner) - 50%

• Review, improve, and digitalize business processes.

• Lead process training and rollout across the maxon Group.

• Validate software supporting manufacturing and business processes (e.g. document macros, machine controls).

• Provide user support for process and software validation topics.

• Deliver statistical training to employees.

• Administer Minitab and SPC for Excel licenses and provide user training.

Document Management (BAE/BPD) – 30%

• Act as Business Application Expert (BAE) for testing and validating implemented User Stories using Azure DevOps.

• Maintain work instructions, processes, and forms within the document management system.

• Further develop Good Documentation Practice (GDP), including training and rollout across the maxon Group.

• Maintain QMS templates within the ERP system (IFS).

• Customize and develop macros in the ERP system.

• Define and implement Data Governance solutions to improve document quality.

• Develop and optimize workflows and digital solutions (e.g. records management, project templates).

Quality Management System (QMS) – 20%

• Take technical responsibility, together with the team, for maintaining and continuously improving the maxon Quality Management System (QMS).

• Establish documentation guidelines and further develop the documented change management process.

• Process tickets related to documents, processes, master data, roles, and access rights.

• Coordinate software maintenance activities, including updates, testing, validation, and user training.

• Maintain the structured mapping of ISO standard requirements applicable to maxon.

You’re the ideal candidate if you:

• University degree in Engineering or a related field.

• At least 5 years of experience in process and software validation.

• Good understanding of the Process Owner role.

• Strong knowledge of regulatory and normative requirements related to process validation.

• Good knowledge of MSA, process validation, and software validation.

• Advanced statistical knowledge and data analysis skills (Lean Six Sigma Black Belt is an advantage).

• Knowledge of GMP and documentation requirements in regulated environments.

• Experience in developing and maintaining Quality Management Systems within regulated industries such as Medical Technology, Aerospace, or Automotive (IATF).

• Strong analytical and problem-solving skills.

• Excellent technical writing, communication, and presentation skills.

• A proactive, collaborative, and open-minded mindset.

• High attention to detail and accuracy.

• Experience in Production Engineering is an advantage.

• Basic programming skills are an advantage

Location:

Veszprém

Business travel: Occasional travel internationally may be required for training sessions and workshops.

About the Employer:

Man at Work Human Services and HR Consulting Ltd. is recruiting a Process Validation & Quality System Expert on behalf of its international partner in Veszprém. We are looking for a senior engineering professional with expertise in process and software validation, Quality Management Systems (QMS), and continuous process improvement to join an international team and contribute to the development of a world-class quality organization.

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