Engineer II, QC

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

LOCATION: This is a fully onsite position based in Madison, WI. Unfortunately, relocation assistance is NOT provided.

• Must be legally authorized to work in the United States without sponsorship now or in the future.

• Must be able to pass a comprehensive background check, which includes a drug screen.

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.

The Analytical Instruments Group (AIG) at Thermo Fisher Scientific provides a broad portfolio of instruments, software, and services that support a wide range of laboratory, production, and field applications. Our solutions are used by customers across pharmaceutical, biotechnology, academic, government, environmental, and industrial markets to advance research, improve productivity, and drive innovation. At the Madison, Wisconsin site, our teams design and manufacture advanced spectroscopy instrumentation used by scientists around the world for research, materials science, energy, and industrial applications.

DESCRIPTION:

Join our Quality Control team at Thermo Fisher Scientific where you'll make meaningful contributions to our mission of enabling customers to make the world healthier, cleaner and safer. As an Engineer/Scientist II, QC, your work will center on strengthening quality frameworks and enabling proactive, data-based decision-making. You'll collaborate cross-functionally to analyze data, identify trends and sources of variability, and implement control strategies to enhance product quality in an analytical instrumentation manufacturing environment. This role offers excellent opportunities for professional growth while working alongside colleagues who share your commitment to science and quality.

Responsibilities:

• Support manufacturing and R&D teams in resolving quality and process-related issues
• Participate on NPI teams to ensure quality requirements are incorporated into product and process designs
• Drive root cause investigations and corrective actions related to component, assembly, and process failures
• Analyze manufacturing and quality data to identify trends, sources of variation, and opportunities for improvement
• Develop and maintain quality documentation, procedures, inspection methods, and control plans
• Promote the utilization of Lean methodologies and quality tools such as Kaizen, 5S, SPC, CAPA, FMEA, and mistake-proofing techniques
• Support process validation, equipment qualification, and implementation of engineering changes
• Partner with Manufacturing Engineering to improve process capability, reduce scrap and rework, and improve overall product reliability
• Engage in supplier quality activities including corrective actions, nonconformance investigations, and first article inspections
• Ensure compliance with applicable quality standards and regulatory requirements including ISO and GMP practices
• Support audits, nonconformance investigations, and continuous improvement initiatives
• Other duties as assigned

REQUIREMENTS:

• Advanced Degree with no prior experience, Bachelor's Degree with 2 years of experience, preferably in a research or manufacturing environment
• Equivalent experience (4 years plus) will also be considered in lieu of a degree. HS diploma / GED is required
• Preferred Fields of Study: Science or Engineering
• Additional certifications in Quality Control/GMP practices beneficial
• Understanding of analytical techniques such as spectroscopy preferred
• Experience in data analysis and investigation of out-of-specification results
• Strong documentation skills and proficiency with information management systems
• Knowledge of relevant regulatory standards (ISO, FDA, USP, EP) preferred
• Excellent attention to detail and ability to follow written/verbal procedures accurately
• Strong organizational and time management skills
• Ability to work both independently and collaboratively in a team environment
• Proficiency in Microsoft Office applications
• Clear written and verbal communication skills in English
• Knowledge of Lean/Six Sigma principles beneficial