Staff Quality Engineer, Ion Chromatography Instruments

Description

The role sits in the Ion Chromatography and Sample Preparation business unit, part of the Chromatography and Mass Spectrometry division, and is based in Brno, Czech Republic.

The team is focused on keeping instruments reliable and customer-ready as the company grows, with room for career development.

The job is a staff-level quality role covering new products and products already on the market.

Responsibilities

• Act as Quality's representative on new product development and introduction core teams.
• Build product quality plans, risk assessments and other assigned quality deliverables.
• Join technical design reviews and help prepare for phase gates.
• Bring field quality lessons into design for reliability, design for manufacturability, DFMEA, PFMEA and verification work.
• Track complaints, field failures, warranty, reliability, manufacturing and COPQ data to spot quality trends and risks early.
• Lead product quality reviews and report performance, risks and priorities to leadership.
• Set and drive quality improvement strategies for your assigned products.
• Lead investigations into customer complaints, escalations and field issues with Product Support, R&D, Manufacturing and other functions.
• Use structured problem-solving methods such as 8D, 5 Why, Fishbone, Fault Tree Analysis and statistical analysis to find root causes.
• Judge customer impact and coordinate containment and corrective actions with the owning functions.
• Lead cross-functional CAPA and wider product quality improvement work.
• Make sure corrective actions fix root causes and prevent recurrence.
• Push gains in reliability, instrument uptime, manufacturing performance and customer experience.
• Work with Operations and Manufacturing Engineering on product and process quality issues.
• Support manufacturing transfers, and process, product and supplier changes, through risk assessment and validation.
• Review engineering changes, deviations and supplier change notices for quality impact.
• Drive reductions in defects and gains in first-pass yield and overall product quality with operations and manufacturing engineering.
• Make sure activities follow Thermo Fisher Quality Management System requirements.
• Keep investigation, CAPA and quality records accurate and compliant.
• Support audits, management reviews and quality system improvements.

Requirements

• Bachelor's degree in mechanical, electrical or systems engineering, or a related technical field.
• At least 5 years in quality engineering, product quality, manufacturing quality, reliability engineering or a similar technical role.
• Experience with new product introductions and with design for quality, manufacturability and reliability.
• Experience working across teams on complex technical products, running root cause investigations and corrective actions in a manufacturing setting.
• Strong analytical and problem-solving skills.
• Working knowledge of CAPA, 8D, FMEA, SPC and statistical analysis methods.
• Ability to work through large datasets and turn findings into practical improvements.
• Strong communication and presentation skills, with the ability to influence people across functions.
• Proven ability to lead complex investigations and reach lasting fixes.
• Experience with quality and business systems such as SAP, Agile, TrackWise, Minitab, JMP, Power BI or equivalents.
• Working knowledge of ISO 9001.
• Valid passport, and willingness to travel regionally and internationally as needed.
• Willingness to shift your working hours to fit communication with other regions.
• Preferred: experience supporting analytical instruments, laboratory equipment or chromatography systems.
• Preferred: experience with electro-mechanical systems, fluidics, detectors, electronics, software-controlled instruments or scientific equipment.
• Preferred: experience supporting manufacturing transfer projects and product lifecycle management.
• Preferred: ASQ Certified Quality Engineer (CQE) or an equivalent certification.

Conditions

Standard Monday to Friday schedule.

Office-based work in Brno, Czech Republic.

Travel regionally and internationally as required.

The company is an equal opportunity employer.