Engineer II, QA at Thermo Fisher Scientific

Marietta, Ohio, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, ManufacturingIndustries

Requirements

High school diploma or equivalent experience required
Bachelor's degree or equivalent experience preferred; applicable experience will be considered
Manufacturing environment experience desired
3 years’ experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred
Knowledge of Regulatory and Quality system requirements (ISO 13485:2016 and 21 CFR Part 820)
Strong analytical and problem-solving skills
Effective communication skills across all organizational levels
Strong technical writing abilities and familiarity with software applications like MS Office or similar, SAP, Salesforce
Strong proficiency in Excel
Strong organizational and interpersonal skills to manage and prioritize multiple tasks
Ability to achieve deadlines in a fast-paced environment
Capability to work independently and collaboratively
Ability to communicate effectively with multiple levels of leadership
Mastery in conducting investigations and root cause analysis for complaints, non-conforming products, and CAPAs
Ability to work standing, walking, and occasionally lifting up to 25 pounds
Adherence to all Good Manufacturing Practices (GMP) Safety Standards and safety protocols
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Responsibilities

Foster a collaborative relationship with Operations to promote a culture of ongoing education on the Quality Management System
Facilitate and participate in Customer / Internal audits
Apply problem-solving skills related to quality issues to ensure timely resolution with minimal impact
Embrace site PPI initiatives and adopt this methodology in day-to-day tasks
Take charge of plant-wide initiatives for addressing and preventing issues, with a key focus on handling customer returns and identifying root causes
Serve as a manufacturing liaison during new product development
Provide Quality mentorship for product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs
Apply 21 CFR Part 820 and standard ISO 13485:2016 principles into critical daily decisions

Skills

ISO 13485

GMP

Quality Management System

Internal Audits

Customer Audits

Root Cause Analysis

Problem Solving

PPI

New Product Development

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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