Senior Quality Engineer at Thermo Fisher Scientific

Singapore

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Life SciencesIndustries

Requirements

Bachelor's degree in Science, engineering or equivalent
Minimum 5 years in QA function with people management
Relevant working experience in quality function dealing with medical devices / IVD devices / ISO 13485 environment preferred
Proactive and assertive attitude
Ability to interface effectively in a global matrix organization environment
Strong communication (verbal and written) and good interpersonal skills with all levels
Trained as internal auditor and lead auditor
Knowledge of statistical controls and data analysis
Experience in Process validation activities as Quality function

Responsibilities

Lead the development and implementation of quality initiatives to address system inadequacies and achieve continual quality improvement objectives
Drive continuous improvement projects through Practical Process Improvement to ensure timely and accurate completion of quality projects and tasks
Work with management to devise and implement quality strategies and policies
Manage internal audits by plan and coordinate to ensure internal audit findings are rectified and corrective action is implemented
Support external audits and follow up on external audit findings and corrective actions
Ensure quality systems and procedures are in compliance with ISO 13485, MDSAP, FDA 21 CFR Part 820, IVDR
Provide management with quality data and trends in product performance in meeting customer requirements
Review customer complaints and analyze data for trends
Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions
Review deviation and risk management for products
Participate in the construction of SOPs, review and approve of COs (Change Order) on changes that affect the quality management system
Support organization in change management which includes QMS and new product release and changes based on approved and released documentation as defined in respective processes, SOP and project responsibilities
Support plant-wide activities and special projects, as assigned

Skills

Key technologies and capabilities for this role

ISO 13485MDSAPFDA 21 CFR Part 820IVDRGMPQMSSOPChange ManagementRisk ManagementData AnalysisContinuous ImprovementInternal AuditsExternal Audits

Questions & Answers

Common questions about this position

What qualifications and experience are required for this Senior Quality Engineer role?

A Bachelor's degree in Science, engineering or equivalent is required, along with a minimum of 5 years in a QA function with people management. Relevant working experience in quality functions dealing with medical devices, IVD devices, or ISO 13485 environments is preferred.

What preferred competencies are needed for this position?

Preferred competencies include a proactive and assertive attitude, ability to interface effectively in a global matrix organization, strong communication and interpersonal skills, training as an internal and lead auditor, knowledge of statistical controls and data analysis, and experience in process validation.

Is this a remote position, or what is the work arrangement?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Senior Quality Engineer position?

Strong candidates will have 5+ years in QA with people management, experience in medical devices or ISO 13485 environments, and preferred competencies like lead auditor training, data analysis skills, and process validation experience.

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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