Staff Quality Engineer

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

This role is in the Single Use Division and will be performed at our Logan, Utah location.

This role calls for a hands-on professional with a robust background in quality, risk assessment, and CAPA investigations.  The ideal candidate will have a strong grasp of ISO and FDA quality frameworks and the ability to lead investigations and continuous improvement initiatives.

• Collaborate with multi-functional team members to support the Customer Feedback/Complaint Handling Process and CAPA process.
• Monitor product quality improvement to ensure execution of actions, including any resulting customer communications/interactions.
• Complete and lead Risk and Impact Assessments.
• Interact directly with customers and internal groups.
• Develop realistic solutions to meet customer needs and address problems.
• Drive product and processing changes to improve product quality.
• Compile and present quality metrics for interna/external reviews
• Communicate recommendations and implement decisions across the organization.

• Minimum Required Education: Bachelor’s degree in engineering or a science-related field
• ASQ certification is desired.

• Required: 8 years of experience in Quality or Operations roles within the biotech, med-device or pharmaceutical industry.
• Direct experience of working with ISO 13485 or ISO 9001 and 21CFR820.

• Strong analytical, problem-solving, and teamwork skills are required.
• Proven understanding of statistical techniques and data trending
• Experience optimally presenting complaints, risks, production, process controls, Corrective and Preventive Actions (CAPA), and improvements.
• Proven experience with using standard quality tools such as 5 Whys, Ishikawa Diagrams, GEMBA walks, etc.
• Ability to analyze and process data and draw the appropriate conclusions.
• Proven knowledge of Quality Management System tools, continuous improvement methodologies, and an in-depth understanding of products and processes.
• Understanding of plastics—materials, properties, manufacturing processes, and product assembly.
• Experience prioritizing conflicting demands.
• Excellent interpersonal, organizational, and influencing skills.
• Proficient with Microsoft tools: Word, Excel, PowerPoint, Visio, Teams; MiniTab.
• Ability to travel; domestic/foreign.

• Annual performance-based bonus
• Annual merit performance-based increase

• Benefits & Total Rewards | Thermo Fisher Scientific
• Medical, Dental, & Vision benefits - Effective Day 1!
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities