Quality Specialist (9001 Certificated) Analytical Instruments

ThermoFisher Scientific; Breda; On-site; EUR 60,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality and Compliance Specialist to ensure regulatory compliance and drive continuous improvement of quality systems across multiple sites in the Netherlands, Denmark, Sweden, the UK and Belgium. You will work with cross-functional teams and a global quality organization to investigate issues, manage audits and oversee CAPA processes.

The role requires advanced degrees or equivalent experience, strong knowledge of GMP/GLP and ISO standards, and excellent

Qualifications

• Advanced degree plus years of work experiences, or Bachelor's Degree plus 5 years in quality assurance.
• Knowledge of EU or USA GMP and GLP regulations plus IQ, OQ, PQ (min 3 years proven) and ISO 9001/13485/17025.
• Experience with quality management systems, CAPA, deviation management and change control; internal auditing experience.
• Root cause analysis and investigation techniques; corrective action implementation.
• Proficiency in statistics, data trending and quality metrics reporting; strong technical writing.
• Fluency in English; Dutch or German language skills preferred.

Responsibilities

• Develop and maintain the data infrastructure for the IES EMEA Quality Team, manage SharePoint sites, workflows and reporting tools, and document control.
• Develop and maintain required certifications for IES sites in scope (ISO 9001:2015/ISO 17025).
• Support quality management needs for IES Enterprise Services across countries in scope; drive continuous improvement.
• Coordinate quality activities with local management, employees, suppliers and customers.
• Create and maintain SOPs, investigations and quality tools on SharePoint.
• Support quality agreements and service contracts with vendors.

Skills

Quality assurance

Auditing

Root cause analysis

Statistical analysis

Documentation

English fluency

Cross-functional collaboration

Education

Advanced degree

Bachelor's degree

Tools

SharePoint

MS Teams

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Description:

Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality and Compliance Specialist, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner and safer.

This role involves collaborating with cross-functional teams, working closely with the Senior Quality Manager, the IES (Instrument & Enterprise Services) EMEA Quality Team and regional management teams and the global quality organisation to investigate quality issues, conduct audits, supplier oversight, manage nonconformities, complaints, deviations, training and implement corrective actions while fostering a culture of quality excellence throughout the organization across the commercial sites in the Netherlands, Denmark, Sweden, the UK and Belgium while assisting local quality administrators and coordinating site-level quality reporting.

In this key role you will

• Develop and maintain the data infrastructure for the IES EMEA Quality Team, manage SharePoint sites, workflows and reporting tools, as well as manage document control.

• Develop and maintain required certifications for IES sites in scope (ISO 9001:2015/ISO 17025), ensuring alignment with EMEA, European and global quality programmes.

• Support quality management needs for IES Enterprise Services in the countries in scope and process continuous improvement initiatives.

• Communicate and coordinate quality-related activities with local management teams, employees, suppliers and customers.

• Create and maintain documentation and quality tools on SharePoint.

• Support quality agreements and service agreements with vendors/suppliers.

Requirements:

• Advanced Degree plus years of work experiences, or Bachelor's Degree plus 5 years of experience in quality assurance/quality control within regulated industries (pharmaceutical, medical device, biotech preferred) or equivalent experience (e.g. in Engineering, Quality)

• Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology or related technical field

• Knowledge of EU or USA GMP and GLP regulations plus IQ, OQ, PQ (minimum 3 years proven experience), ISO standards (9001/13485/17025) and other relevant quality system requirements

• Confirmed experience with quality management systems, CAPA processes, deviation management and change control, trained as internal auditor or having extensive experience of auditing is a must have.

• Demonstrated expertise in root cause analysis, investigation techniques and corrective action implementation

• Proficiency in statistical analysis, data trending and quality metrics reporting

• Strong technical writing skills for authoring SOPs, investigation reports and other quality documentation

• Experience conducting and hosting internal/external audits and regulatory audits

• Advanced problem-solving abilities and attention to detail

• Excellent verbal and written communication skills, fluency in English with additional proficiency in Dutch and/or German preferred

• Strong interpersonal skills with ability to collaborate across functions and levels

• Proficiency with quality systems software (Document Control Systems) and extended knowledge in Microsoft Office applications, including SharePoint and Ms Teams

• Strong commercial competence and customer-centric approach, with great interpersonal skills and the ability to work independently

• May require up to 0-25 % travel

• Knowledge of risk assessment methodologies and continuous improvement tools

At Thermo Fisher Scientific, we are committed to fostering a diverse and inclusive workplace. We offer competitive compensation, excellent benefits, and opportunities for professional growth. Join our team and contribute to life-changing innovations that improve human health worldwide.

Thermo Fisher Scientific does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.