Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
DESCRIPTION:
When you’re part of the team at Thermo Fisher Scientific, you'll do important work. We are dedicated to ensuring our customers receive the products they need to achieve their scientific goals quickly and safely. As we continue to grow, you'll have career advancement and learning opportunities in a culture that empowers your development. We give our people the resources and opportunities to make significant contributions to the world. Now is an exciting time to join our Quality team!
Location/Division Specific Information
Brno, Czech Republic
Ion Chromatography and Sample Preparation Business Unit within the Chromatography and Mass Spectrometry Division
How will you make an impact?
The Staff Quality Engineer drives product quality and reliability across the full product lifecycle of Ion Chromatography and Sample Preparation instruments. Serving as the quality representative for new and on-market products, this role partners with R&D, Manufacturing, Service, Supply Chain, Supplier Quality, and Product Management to identify quality risks, resolve product issues, and improve customer experience.
The role uses field, complaint, warranty, manufacturing, and reliability data to lead root cause investigations, corrective actions, and continuous improvement initiatives that improve product performance and reduce Cost of Poor Quality (COPQ).
New Product Development
- Represent Quality on new product development and introduction core teams.
- Develop and coordinate product quality plans, risk assessments, and assigned quality deliverables
- Participate in technical design reviews and support phase gate preparation
- Apply field quality lessons learned to Design for Reliability, Design for Manufacturability, DFMEA, PFMEA, and verification activities.
Product Quality Ownership
- Monitor product quality using complaints, field failures, warranty, reliability, manufacturing, and COPQ data.
- Identify emerging quality trends and risks through data analysis and cross-functional review.
- Lead product quality reviews and communicate performance, risks, and improvement priorities to leadership.
- Develop and drive quality improvement strategies for assigned products.
Customer and Field Quality
- Lead investigations of customer complaints, escalations, and field performance issues.
- Partner with Product Support, R&D, Manufacturing, and other functions to determine root cause and implement effective corrective actions.
- Apply structured problem-solving tools such as 8D, 5 Why, Fishbone, Fault Tree Analysis, and statistical analysis.
- Assess customer impact and coordinate appropriate containment and corrective actions with responsible functions.
CAPA and Continuous Improvement
- Lead cross-functional CAPA and systemic product quality improvement activities.
- Ensure corrective actions address root causes and effectively prevent recurrence.
- Drive improvements in product reliability, instrument uptime, manufacturing performance, and customer experience.
Manufacturing and Change Management
- Partner with Operations and Manufacturing Engineering to resolve product and process quality issues.
- Support manufacturing transfers, process changes, product changes, and supplier changes through risk assessment and validation.
- Review engineering changes, deviations, and supplier change notifications for quality impact.
- Drive improvements in defect reduction, first-pass yield, and overall product quality in partnership with operations and manufacturing engineering.
Quality Systems Compliance
- Ensure activities comply with applicable Thermo Fisher Quality Management System requirements.
- Maintain accurate and compliant investigation, CAPA, and quality records.
- Support audits, management reviews, and quality system improvement initiatives.
How will you get here?
Education
- Bachelor’s degree in Mechanical, Electrical, Systems Engineering or related technical field required.
Experience
Required:
- 5+ years of experience in Quality Engineering, Product Quality, Manufacturing Quality, Reliability Engineering, or related technical role.
- Experience with new product introductions, design for quality, manufacturability, reliability.
- Experience working in cross-functional teams supporting complex technical products with root cause investigations and corrective actions in a manufacturing environment.
Preferred:
- Experience supporting analytical instrumentation, laboratory equipment, chromatography systems.
- Experience with electro-mechanical systems, fluidics, detectors, electronics, software-controlled instrumentation, or scientific equipment.
- Experience supporting manufacturing transfer projects and product lifecycle management activities.
- ASQ Certified Quality Engineer (CQE) or equivalent certification.
Knowledge, Skills, Abilities
- Strong analytical and problem-solving skills.
- Knowledge of quality engineering tools including CAPA, 8D, FMEA, SPC, and statistical analysis methods.
- Ability to analyze large datasets and translate findings into actionable improvements.
- Strong communication and presentation skills with the ability to influence stakeholders across multiple functions.
- Demonstrated ability to lead complex investigations and drive sustainable solutions.
- Experience using quality and business systems such as SAP, Agile, TrackWise, Minitab, JMP, Power BI, or equivalent tools.
- Demonstrated working knowledge of ISO 9001
- Must maintain a valid passport and travel regionally and internationally as required and be ready to adjust working time to accommodate communication needs with other regions.