quality manager 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, Manufacturing, HealthcareIndustries

Requirements

Bachelor’s degree in medical device, life science, chemistry, or a closely related field
Over 5 years of professional experience in quality management within the medical device industry
In-depth knowledge of GSP, ISO 13485 regulations
Proficient in English (both oral and written)
Demonstrated ability to manage people with strong interpersonal skills for collaborating across teams and working with interested parties

Responsibilities

Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement
Coordinate documentation management to ensure the efficiency of the quality system
Conduct regulatory intelligence to monitor and act on relevant laws and standards
Manage quality control functions and operational permissions of computer information systems
Review and dynamically manage the qualifications of medical device suppliers, products, and purchasers
Confirm and supervise the handling of non-conforming medical devices
Coordinate the verification and calibration of relevant facilities and equipment
Implement UDI to ensure medical device traceability
Investigate, handle, and report medical device quality complaints and incidents
Manage medical device recalls and quality safety risk consultations
Collect and report adverse events related to medical devices

Skills

Key technologies and capabilities for this role

ISO 13485GSPQuality System ManagementRegulatory ComplianceSupplier QualificationEquipment CalibrationUDIPost-Market SurveillanceMedical Device RecallsAdverse Event ReportingDocumentation Management

Questions & Answers

Common questions about this position

What qualifications are required for the Quality Manager position?

Candidates need a Bachelor’s degree in medical device, life science, chemistry, or a closely related field, over 5 years of professional experience in quality management within the medical device industry, in-depth knowledge of GSP and ISO 13485 regulations, proficiency in English (both oral and written), and demonstrated ability to manage people with strong interpersonal skills.

What is the work schedule or location for this role?

The position is full-time with standard office hours (40 hours per week) in an office environment.

What is the salary or compensation for the Quality Manager role?

This information is not specified in the job description.

What does the team culture feel like at Thermo Fisher Scientific?

The role involves joining a driven team committed to flawless implementation, industry-leading benchmarks, regulatory compliance, continuous improvement, and promoting a healthier, cleaner, and safer world.

What makes a strong candidate for this Quality Manager position?

A strong candidate will have over 5 years of quality management experience in the medical device industry, deep knowledge of GSP and ISO 13485, people management skills, and proficiency in English to handle regulatory compliance and team collaboration 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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