quality specialist at Thermo Fisher Scientific

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Life SciencesIndustries

Requirements

Secondary vocational school education or above in medical laboratory inspection or related fields such as laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, or medical devices
Over 1 year of professional experience in clinical inspection or medical device incoming inspection
Knowledge of GSP and ISO 13485
Proficient in English, both reading and writing

Responsibilities

Take charge of quality operations across all products and supervise the process of handling nonconforming product disposition
Monitor and perform incoming inspections, releasing products based on results
Complete related system operations for product control
Review qualifications of medical device suppliers, products, and purchasers, implementing dynamic management
Confirm and supervise handling processes for non-conforming medical devices
Manage rework and labeling processes
Evaluate and approve product returns

Skills

Key technologies and capabilities for this role

ISO 13485GSPIncoming InspectionsNonconforming Product DispositionSupplier QualificationRework ProcessesLabeling ProcessesProduct ReturnsQuality ControlMedical Device Inspection

Questions & Answers

Common questions about this position

What education and experience are required for the Quality Specialist role?

Candidates need secondary vocational school education or above in fields like medical laboratory inspection, laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, or medical devices, plus over 1 year of professional experience in clinical inspection or medical device incoming inspection.

What specific knowledge and skills are needed for this position?

Required knowledge includes GSP and ISO 13485, along with proficiency in English reading and writing.

Is this a remote position, or does it require office work?

This is a full-time office-based role with standard office hours (40 hours per week) in an office environment.

What is the salary or compensation for the Quality Specialist position?

This information is not specified in the job description.

What makes a strong candidate for this Quality Specialist role?

A strong candidate will have the required education in relevant medical or lab fields, over 1 year of experience in clinical or medical device inspection, knowledge of GSP and ISO 13485, and English proficiency to handle quality operations effectively.

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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