Quality Engineer III at Thermo Fisher Scientific

Logan, Utah, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, BiotechnologyIndustries

Requirements

Bachelor’s degree in an Engineering or science related field
5 years of experience in an Engineering, Quality, or Regulatory capacity (preferably within the medical device, biotech, or pharmaceutical sector)
Direct experience working with ISO 13485, ISO 9001, and 21CFR820
Prior ISO 14971 experience preferred
Prior statistical analysis and sample size determination experience preferred
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 desired

Responsibilities

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

Skills

CAPA

ISO

FDA

5-Whys

Root Cause Analysis

Risk Assessment

Complaint Handling

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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