ORGENTEC Diagnostika GmbH is the global market leader in the development and production of test systems for the diagnosis of infectious and autoimmune diseases. As part of the Sebia Group, headquartered in Lisses/France, ORGENTEC supplies medical laboratories in over 100 countries with highly specialised and innovative devices and test kits. Our company is characterised by steady and sustainable growth in an internationally oriented, future-oriented business field.
To strengthen our team at the Mainz site, we are looking for a

SKILLS:

• Bachelor’s degree in Engineering, Quality, or a related field. Advanced degree (e.g., Master’s, MBA) is a plus.
• Initiative
• Ability to work in a team
• Commitment
• Assumption of responsibility
• Performance orientation
• Ability to change
• Customer orientation
• Entrepreneurial thinking (managers)
• Decision-making ability (managers)

Wir bieten:

• Permanent employment contract
• A crisis-proof job with an attractive income
• No shift work
• Flexible working hours
• Individual employee development and further training
• Attractive package of health and social benefits (e.g. subsidised computer glasses, flu vaccination, employer contribution to private pension scheme)
• Employer subsidy for canteen, free drinks
• Nursery and kindergarten subsidy
• Employee discounts with well-known brands
• Anniversary bonus

Supplier Quality Management:

• Manage and maintain the Supplier Quality Management Program to ensure suppliers meet required quality and regulatory standards.
• Conduct supplier audits, assessments, and performance evaluations to ensure compliance with FDA, ISO 13485, and other applicable regulations.
• Work closely with suppliers to address and resolve quality issues, monitor corrective actions, and verify effectiveness of corrective actions.
• Develop and manage supplier quality agreements, contracts, and specifications.
• Lead the Supplier Corrective Action Request (SCAR) process, tracking progress and ensuring resolution of supplier non-conformances.

Collaboration and Communication:

• Serve as the key point of contact for quality-related issues with suppliers, providing guidance and support to ensure timely issue resolution.
• Work collaboratively with cross-functional teams (e.g., R&D, Operations, Procurement, Regulatory Affairs) to ensure that supplier quality aligns with product development and production timelines.
• Communicate regularly with internal stakeholders about supplier quality performance, issues,  and potential risks.

Continuous Improvement:

• Drive supplier quality improvement initiatives, including root cause analysis, risk assessments, and process optimization to reduce non-conformances.
• Monitor and report on key quality metrics (e.g., supplier defects, process yields, on-time delivery) to ensure continuous supplier performance improvement.

Regulatory Compliance:

• Ensure that all purchased components and materials meet the regulatory and quality requirements outlined in the company’s quality system.
• Support preparation for internal and external audits related to supplier quality, including FDA, ISO 13485, and other regulatory inspections.

Documentation and Reporting:

• Maintain thorough documentation of supplier audits, assessments, and quality performance.
• Prepare reports on supplier quality performance, quality risks, and audit results for management and regulatory bodies