QA Qualification Engineer (M/W/X)

AMARIS GROUP SA; Beerse; Hybride; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Group SA is seeking a QA Qualification Engineer to support process equipment qualification activities and maintain audit readiness. You will review risk assessments, qualification deliverables, and procedures, addressing deviations through CAPAs, while staying current with international regulations and industry practices.

You will collaborate with cross-functional teams to ensure on-time project delivery and overall quality and compliance across lifecycle management.

Qualifications

• Experience as a QA professional in a regulated environment.
• Experience in qualification activities and application of risk-based methodologies is preferred.
• Strong quality and compliance mindset.
• Ability to challenge constructively while maintaining positive relationships with stakeholders.

Responsabilités

• Provide QA support for process equipment qualification activities, focusing on risk assessments.
• Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, scripts, reports).
• Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems.
• Ensure deviations are assessed, investigated, and addressed through CAPAs.
• Maintain knowledge of international regulations and industry practices related to system qualification.
• Support regulatory inspections, customer audits, and internal assessments for audit readiness.
• Collaborate with cross-functional stakeholders to meet project timelines and objectives.

Connaissances

QA in regulated env

Risk-based methods

Quality mindset

Stakeholder collaboration

Description du poste

Join our Life Sciences team and play a key role in ensuring the quality and compliance of process equipment qualification activities. As a QA Qualification Engineer (M/W/X), you will support qualification projects, maintain audit readiness, and collaborate with cross-functional teams to achieve organizational objectives.

Your missions

• Provide QA support for process equipment qualification activities, focusing on the review of risk assessments to ensure alignment with current quality principles
• Participate in change projects throughout the system lifecycle, reviewing and approving qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, qualification reports) to ensure compliance with regulations and industry standards
• Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems
• Ensure that deviations related to systems are appropriately assessed, thoroughly investigated, and effectively addressed through corrective and preventive actions
• Maintain a current understanding of international regulations, guidelines, and industry practices related to system qualification, applying this knowledge to improve qualification processes
• Support regulatory inspections, customer audits, and internal compliance assessments by ensuring audit readiness and providing subject matter expertise
• Collaborate closely with cross-functional stakeholders involved in qualification and lifecycle management activities to ensure project timelines and organizational objectives are met

Your profile

• Experience as a QA professional in a regulated environment
• Experience in qualification activities and application of risk-based methodologies is preferred
• Strong quality and compliance mindset
• Ability to challenge constructively while maintaining positive and productive relationships with stakeholders

What we offer

Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.

In practical terms, here’s what this means for you on a daily basis:

Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.

Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.

A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged.

Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.

CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.

Health insurance, remote work, meal vouchers, time savings account, referral bonus… Find the full benefits breakdown at our dedicated page.

Mantu is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

#LI-ML5

Who are we?

Join our Life Sciences team and play a key role in ensuring the quality and compliance of process equipment qualification activities. As a QA Qualification Engineer (M/W/X), you will support qualification projects, maintain audit readiness, and collaborate with cross-functional teams to achieve organizational objectives.

Your missions

• Provide QA support for process equipment qualification activities, focusing on the review of risk assessments to ensure alignment with current quality principles
• Participate in change projects throughout the system lifecycle, reviewing and approving qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, qualification reports) to ensure compliance with regulations and industry standards
• Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems
• Ensure that deviations related to systems are appropriately assessed, thoroughly investigated, and effectively addressed through corrective and preventive actions
• Maintain a current understanding of international regulations, guidelines, and industry practices related to system qualification, applying this knowledge to improve qualification processes
• Support regulatory inspections, customer audits, and internal compliance assessments by ensuring audit readiness and providing subject matter expertise
• Collaborate closely with cross-functional stakeholders involved in qualification and lifecycle management activities to ensure project timelines and organizational objectives are met

Your profile

• Experience as a QA professional in a regulated environment
• Experience in qualification activities and application of risk-based methodologies is preferred
• Strong quality and compliance mindset
• Ability to challenge constructively while maintaining positive and productive relationships with stakeholders

What we offer

Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.

In practical terms, here’s what this means for you on a daily basis:

Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.

Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.

A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged.

Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.

CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.

Health insurance, remote work, meal vouchers, time savings account, referral bonus… Find the full benefits breakdown at our dedicated page.

Mantu is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting isan independent technologyconsulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of7,600 people spread across 5 continents and more than 60countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!