"Alerted.org

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

Location/Division Specific Information:

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

How You Will Make an Impact:

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 across both development and production environments.

What will you do?

+ Lead cross-functional team members supporting 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 Risk and Impact Assessments.

+ Interface directly with customers and internal groups.

+ Develop realistic solutions to meet customer needs and solve problems.

+ Drive product and process changes to improve product quality.

+ Provide support to QE team members.

+ Communicate recommendations and decisions across the organization.

+ Apply problem-solving tools (8D, 5-whys, cause and effect, etc.).

+ Demonstrate strong root cause/corrective action skills.

How will you get here?

Education:

+ Bachelor’s degree in an Engineering or science related field required

Experience:

+ 5 years of experience in an Engineering, Quality, or Regulatory capacity required (preferably within the medical device, biotech, or pharmaceutical sector)

+ Direct experience working with ISO 13485, ISO 9001, and 21CFR820 required.

+ Prior ISO 14971 experience preferred.

+ Prior statistical analysis and sample size determination experience preferred.

Knowledge, Skills, and Abilities:

+ Strong analytical, problem-solving, and teamwork skills.

+ Proficient with Microsoft tools (Word, Excel, PowerPoint, Visio, Teams) and MiniTab.

+ Excellent written and verbal communication skills.

+ Ability to analyze and process data and draw appropriate conclusions.

+ Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.

+ Understanding of plastics materials, properties, manufacturing processes, and product assembly.

+ Experience prioritizing conflicting demands.

+ Excellent interpersonal, organizational, and influencing skills.

+ CQE Certification or ASQ certification is desired.

What We Offer:

+ Annual performance-based bonus

+ Annual merit performance-based increase

Excellent Benefits:

+ 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.