Supervisor, Quality

TL;DR

Supervisor, Quality (Manufacturing): Managing daily quality operations in production in accordance with ISO 13485 and ISO 9001 standards with an accent on process performance, deviation analysis, and CAPA implementation. Focus on leading a team of quality inspectors, overseeing validations (IQ/OQ/PQ), and ensuring compliance within a cleanroom environment.

Location: Must be based in Prelouc, Czech Republic

Компания

hirify.global is a global leader in delivering precision components and sub-systems for mission-critical applications in healthcare and advanced manufacturing.

Что делать

• Manage daily quality operations and ensure compliance with ISO 13485 and ISO 9001 standards.
• Analyze root causes of deviations and customer complaints using quality tools like 8D, 5Why, and Ishikawa.
• Lead and develop a team of quality inspectors, including shift planning and performance evaluations.
• Oversee validation processes (IQ/OQ/PQ) and monitor cleanroom microbiological results.
• Collaborate with production, engineering, and external suppliers to maintain high quality standards.
• Participate in internal and external quality audits and Gemba walks.

Требования

• Fluent Czech language proficiency required.
• English language at a communicative level (daily use).
• Proven experience with EN ISO 13485 and EN ISO 9001 standards.
• Strong knowledge of quality tools (5Why, Ishikawa, 8D report).
• Experience with technical documentation and MS Office.
• Willingness to travel (less than 30% of working time).

Культура и преимущества

• Global team environment with a focus on collaboration and empowerment.
• Opportunity to work on innovative technology for healthcare and robotics.
• Professional development within a global organization.