Process Validation & Quality System Expert

This is a senior Quality Management and Process Excellence role responsible for leading process and software validation activities, supporting document management, and continuously developing the company's Quality Management System (QMS). Working closely with international stakeholders, you will ensure regulatory compliance, drive process digitalization, and support business users across the global maxon organization. Key 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., Fluent English and good German language skills, both used in daily business communication.
• Business travel:

Occasional travel internationally may be required for training sessions and workshops. At maxon, we believe that by working together as one team, we can overcome any challenge. We foster a strong team spirit through a variety of company events that help our employees enjoy their time with us and build lasting connections.

We provide a family-like working environment where respect, care, and people truly matter. Our continuously expanding product portfolio and international environment offer excellent opportunities for personal and professional growth. By supplying high-quality products to a wide range of industries, we also ensure the long-term stability of our business.

• 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