Director of Quality at Thermo Fisher Scientific

Singapore

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Genetic Science, Medical DevicesIndustries

Skills

Key technologies and capabilities for this role

Quality SystemsQuality AssuranceQMS21 CFR 820ISO9001ISO 13485MDSAPCE-IVDDCE-IVDRContinuous ImprovementCAPAInternal AuditsNPILeadershipTeam DevelopmentStrategic PlanningRegulatory Compliance

Questions & Answers

Common questions about this position

What experience is required for the Director of Quality position?

A minimum of 15 years of professional quality experience within the Life Sciences, Medical Device, Pharmaceutical, or IVD industry is required, along with a Bachelor’s degree in science or engineering fields or equivalent experience.

What is the work arrangement and location for this role?

This is a full-time position with a standard Monday-Friday schedule in an office environment at the Singapore - Marsiling and Gul Circle sites.

What quality standards must the role ensure compliance with?

The role requires developing and ensuring adherence to quality systems aligned with 21 CFR 820, ISO9001, ISO 13485, MDSAP, CE-IVDD, and CE-IVDR.

What leadership responsibilities does the Director of Quality have?

The role involves leading and inspiring the site quality organization by hiring and developing quality leaders, setting performance expectations, and providing development and training opportunities.

What makes a strong candidate for this Director of Quality role?

Strong candidates prioritize customer needs, demonstrate expertise in implementing quality systems like ISO 9001, ISO 13485, and MDSAP, and have extensive experience in regulated life sciences industries.

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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