Quality System and Equipment Specialist

JOB DESCRIPTION:

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.

Sounds interesting?

We are conducting recruitment on an ongoing basis and will close the process as soon as the right candidate is found. If you meet the qualifications and are interested in this opportunity, we encourage you to apply as soon as possible following the link above.

The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.

## JOB FAMILY:
Operations Quality

## DIVISION:
EP Electrophysiology

## LOCATION:
Belgium : Bedrijvenzone Machelen - Cargo 831

ADDITIONAL LOCATIONS:

## WORK SHIFT:
Standard

## TRAVEL:
Not specified

## MEDICAL SURVEILLANCE:
Not Applicable

## SIGNIFICANT WORK ACTIVITIES:
Not Applicable