Quality Manager (m/w/d) - Medical Technology

About the Role

We are seeking a Quality Manager for a respected, globally active medical technology company based in Baden-Württemberg, Germany. This role offers a hands-on leadership position deeply engaged in quality management within a regulated environment adhering to ISO 13485, EU-MDR, and 21 CFR 820 standards. You will work closely with production teams to actively drive quality initiatives rather than simply administering processes.

Key Responsibilities

• Manage complaint handling and CAPA processes, including root cause analysis, implementation of corrective actions, and reporting.
• Conduct process and product validations and qualifications (IQ/OQ/PQ) following regulatory requirements in a manufacturing setting.
• Organize and execute audit programs encompassing internal audits, supplier audits, and audits by authorities/notified bodies, covering system, process, and product evaluations.
• Maintain quality management documentation, oversee training programs, and manage the qualification matrix.
• Lead weekly quality meetings and ensure diligent follow-up on outstanding quality issues.
• Provide leadership to the quality team, fostering close cooperation with production.

Candidate Profile

• Technical education background such as an engineering degree, technician certification, or business administration qualification.
• Extensive experience in quality management and quality assurance within regulated manufacturing environments, especially related to complaints handling, CAPA, and audits compliant with ISO 13485, MDR, and 21 CFR 820.
• Several years of expertise in validations (process validation, IQ/OQ/PQ, possibly CSV) – this is a key requirement for this position.
• A proactive, practical, and results-oriented work style, taking responsibility and actively advancing projects.
• Strong familiarity with quality methodologies and statistical tools.
• Fluency in German and good command of English.
• Leadership capability, whether experienced in managing teams already or aspiring to take the first formal leadership role.

What You Can Expect

• An influential quality management position with responsibility and visibility from day one.
• A stable, well-funded company offering long-term career prospects.
• Primarily onsite work in Baden-Württemberg with some flexibility after initial training.
• A competitive compensation package tailored to your experience, discussed during the interview.