Quality Engineer at Thermo Fisher Scientific

Stafford Springs, Connecticut, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Manufacturing, Life SciencesIndustries

Requirements

Bachelor’s degree in Engineering, Science, or Technical related field
Minimum of 5 years of experience as a Quality Professional
Direct experience with ISO 9001 or ISO 13485 is a plus
Strong analytical, problem-solving, and teamwork skills
Demonstrated understanding of statistical techniques and data trending
Proficiency with quality tools such as 5 Whys, Ishikawa Diagrams, and GEMBA walks
Excellent interpersonal, organizational, and influencing skills
Proficient with Microsoft Office tools: Word, Excel, PowerPoint, Visio, Teams; MiniTab
ASQ certification is preferred
Strong leadership and communication skills
Ability to manage and implement changes with minimal supervision
Experience in continuous improvement/lean processes
Capability to persuade and discuss with collaborators to address concerns
Ability to analyze data, draw appropriate conclusions, and make rational decisions and recommendations
Experience working in a fast-paced technical environment and making technical decisions
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Responsibilities

Own the Customer Complaint Handling Process, ensuring detailed investigation and resolution
Coordinate with Division Quality regarding all aspects of Risk and Impact Assessments related to customer complaints
Interact directly with customers and internal teams to address and resolve quality issues
Develop and implement corrective and preventive actions (CAPA) to address root causes of complaints and trends in internal nonconformances
Monitor and report on product quality improvements and ensure execution of necessary actions
Compile and present quality metrics for internal and external reviews
Support external audits (customer and regulatory) and ensure corrective/preventive actions are implemented for identified non-conformances
Communicate recommendations and implement decisions across the organization to improve product quality and customer satisfaction
Perform and guide approved self-initiated quality activities in support of the Quality Management System
Coordinate customer complaints, ensuring timely and effective resolution
Lead investigations, implementing corrective actions, and driving continuous improvement initiatives
Work closely with cross-functional teams and report directly to the Quality Manager, collaborating with the Plant Facilities and Engineering

Skills

GMP

CAPA

Root Cause Analysis

Customer Complaint Handling

Quality Audits

Risk Assessment

Continuous Improvement

Quality Metrics

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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