QA Qualification Engineer (M/W/X)

MANTU GROUP SA; Beerse; Sur place; 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 Consulting is seeking a QA Qualification Engineer to support process equipment qualification, maintain audit readiness, and collaborate with cross-functional teams to meet regulatory expectations. Your missions include reviewing risk assessments, approving URS, DQ/IQ/OQ/PQ protocols and qualification reports, and ensuring deviations are investigated and CAPAs implemented.

You should have at least 4 years in QA within a regulated environment, knowledge of qualification activities and

Qualifications

• Min 4 years 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.
• Strong communication skills.
• English fluent, Dutch is a plus.

Responsabilités

• 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.

Connaissances

Quality mindset

Communication skills

Risk-based methodologies

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

• Min 4 years 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
• English fluent, Dutch is a plus

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.

Amaris 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?

Job description

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

• Min 4 years 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
• Strong communication skills
• Ability to challenge constructively while maintaining positive and productive relationships with stakeholders
• English fluent, Dutch is a plus

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.

Amaris 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 is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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 of 7,600 people spread across 5 continents and more than 60 countries. 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. 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!