Quality System and Equipment Specialist
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Quality System & Equipment Specialist
Are you passionate about quality, compliance, and continuous improvement? Do you enjoy working at the intersection of quality systems, equipment management, validation, and operational excellence?
We're looking for a Quality System & Equipment Specialist to join our Quality team and play a key role in maintaining and continuously improving our Quality Management System while ensuring equipment and computerized systems remain compliant, efficient, and inspection-ready.
In this role, you'll collaborate with stakeholders across the organization and contribute to activities that directly impact quality performance, regulatory compliance, and business operations.'
Location: Machelen, Belgium. This is an office based position.
What you'll do
As our Quality System & Equipment Specialist, you will:
- Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
- Support key quality processes such as CAPA, Change Control, Risk Management, Document Control, training activities, and audit follow-up
- Manage equipment lifecycle activities, including qualification, calibration, and preventive maintenance follow up..
- Support the validation, implementation, maintenance, and review of computerized systems and spreadsheets.
- Create and maintain reports and dashboards, including Power BI reporting to support quality..
- Support internal, externalaudits and ensure corrective and preventive actions are effectively implemented.
- Provide quality oversight of operational activities, including non-conforming materials, inspections, quarantine, and other regulated processes.
- Participate in continuous improvement projects and promote a strong quality culture across the organization.
What we're looking for
We're looking for someone who combines a strong quality mindset with a proactive and detail-oriented approach.
Qualifications:
- University degree in Life Sciences, Engineering, Biomedical Sciences, Quality, or a related field.
- At least 1 year of experience within a Quality Management System, Quality Assurance, Validation, or Equipment Lifecycle Management.
- Familiarity with QMS processes such as CAPA, Change Control, Risk Management, and Document Control.
- Understanding of equipment qualification and computerized systems validation principles.
- Experience with equipment qualification, validation activities, CSV, or quality systems is highly desirable.
- Knowledge of Power BI is an advantage.
- Professional proficiency in English is required, both written and spoken.
You'll thrive in this role if you are:
- A quick learner who enjoys working in a dynamic environment.
- Analytical and solutions-oriented.
- Detail-oriented and highly organized.
- Comfortable managing multiple priorities.
- An effective communicator who enjoys collaborating across teams.
- Passionate about quality and continuous improvement.
Why join us?
This role offers a unique opportunity to gain broad exposure across Quality Systems, Equipment Management, Validation, Compliance, Audits, and Continuous Improvement. You'll work in a collaborative environment where quality plays a critical role in everything we do, and where you'll have the opportunity to make a visible impact from day one.