Quality Specialist

Role Information

As a Quality Specialist at their Schwaikheim site, you will be a key driver in ensuring that our products and processes meet the highest standards of safety and efficacy. You will be part of a culture of belonging where your unique viewpoint matters, using the Danaher Business System (DBS) to turn ideas into impact.

Key Responsibilities

In this role, you will be responsible for the daily management of quality control and assurance activities. Your primary focus will be:

1. Compliance Management: Ensure all procedures and activities align with applicable regulatory requirements (e.g., ISO 13485, IVDR, FDA QMSR).

2. CAPA & Audits: Act as a specialist for Corrective and Preventive Actions (CAPA) and lead/support internal and external audits to identify trends and areas for improvement.

3. Inspections: Verify the quality of incoming goods, assemblies, and finished products against strict specifications and quality standards.

4. Process Improvement: Utilize DBS tools to streamline quality workflows, reduce waste, and enhance operational excellence.

5. Documentation: Maintain rigorous Good Documentation Practices (GDP) to ensure traceability and audit readiness at all times.

6. Collaboration: Work closely with Custom Engineering, Manufacturing, and Supply Chain teams to resolve quality issues and prevent recurrences.

Requirements

1. Education: University degree in Science, Engineering, Technology, or a related technical field.

2. Experience: Minimum of 3+ years of professional experience in Quality Management or Regulatory Affairs, preferably within the Medical Device or Biopharmaceutical industry.

3. Technical Knowledge: Deep understanding of ISO 13485 and IVDR/MDR regulations. Knowledge of GMP (Good Manufacturing Practice) is essential.

4. Languages: Fluency in German and English (both written and spoken) is required.

5. Skills: Strong analytical mindset with the ability to interpret complex quality data. Excellent communication skills and a collaborative “team-player” attitude.