Quality Sr. Specialist at Thermo Fisher Scientific

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Biotechnology, Life SciencesIndustries

Requirements

College Degree or higher in medical laboratory inspection or related fields such as laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, or medical devices
License of chief medical/laboratory technician
Over 3 years of professional work experience in clinical inspection
Knowledge of GSP and ISO 13485
Proficiency in English, both reading and writing

Responsibilities

Lead the quality operations for all products and manage the disposition of nonconforming products
Monitor and manage incoming inspections, ensuring products are released according to inspection results
Coordinate supervision and quality management activities with third-party warehouses
Support the management of post-market surveillance, including handling complaints and coordinating investigations and responses
Prioritize or coordinate medical device recalls
Implement medical device quality safety risk consultations, such as periodical risk evaluation reports
Submit and report adverse events related to medical devices

Skills

ISO 13485

GSP

Incoming Inspections

Post-Market Surveillance

Nonconforming Products

Medical Device Recalls

Risk Evaluation

Adverse Event Reporting

Complaint Handling

Quality Control

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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