Project Quality Engineer
Department: Quality
Employment Type: Permanent - Full Time
Location: invoX Belgium N.V.
Reporting To: Iain Breakwell
Description
Why This Role Matters
At invoX Respiratory Innovation Centre, we are not just developing medical devices; we are reshaping the future of respiratory healthcare. In this role, you will be part of a close-knit, purpose-driven team dedicated to pioneering drug-device combination therapies. Every decision you make and every document you review will play a vital role in helping patients breathe easier and live better lives.
To help continue our growth and success, we are looking for a Project Quality Engineer to join our Quality team in Diepenbeek (Belgium), reporting to the Head of Project Quality.
You will have responsibility for QA review of documentation supporting formulation, analytics and device development and manufacturing activities related to SMI, to ensure adherence to applicable regulatory GxP and Medical Device guidance.
As a key member of the development team, you’ll work within a complex matrix environment with multiple stakeholders and on cross-functional teams to advise on drug and device development processes, quality requirements and global quality standards. Supporting technical R&D colleagues you’ll develop approaches to enable compliant development project delivery.
At invoX Belgium NV, development is achieved through an outsourcing model, so you’ll work with key development and manufacturing partners, coming to understand in detail about their documentation and processes. Additionally, you’ll be expected to travel to many of these key development partners from time to time, reviewing on-site where required.
Key Responsibilities
Document Review:
* QA review of Invox Belgium project documents and records as necessary (including Design Control, Risk Management, Design Review).
* QA review of vendor project documents and records as necessary (including protocols, reports, methods, validation and batch records).
* Quality oversight of vendor data investigations (Out of Specification (OOS) and Deviation management).
* A Quality function signatory on internal/ external project documents.
Vendor Compliance Monitoring:
* Preparation of Quality materials for Project team meetings.
* Maintenance, compilation, and analysis of Vendor Quality metrics.
Supporting work in the following area:
* Maintenance of company certifications (ISO 13485).
* Continuous Improvement (CI) of the documents and systems of the QMS.
* Preparation and reporting of external audits.
* Establish Pre-Approval Inspection (PAI) readiness at strategic commercial partners.
What You Need to Succeed
Education:
* Bachelor’s or higher degree in science, engineering, or an equivalent field.
Experience:
* Significant experience in a Quality role within the pharmaceutical industry.
* In-depth knowledge of drug product development and GMP.
* Familiarity with ISO 13485 and/or USFDA medical device guidance is highly desirable.
* Experience or interest in respiratory diseases.
* Proven success working in a complex, matrix environment with multiple stakeholders and cross-functional teams.
Technical Skills:
* Strong understanding of regulatory quality standards and documentation.
* Ability to manage vendor compliance and quality metrics effectively.
Soft Skills:
* Proactive, hands-on problem-solver.
* Excellent written and spoken English.
* Strong communication and collaboration skills.
* Eager to work in an international environment and occasionally travel to vendor sites.
What Sets invoX Apart?
* Purpose-Driven Work: Every task contributes to reshaping respiratory healthcare.
* A Collaborative Community: Work with passionate professionals who share your drive for excellence.
* Career Growth: Continuous learning opportunities
* Global Impact: Be part of a company delivering solutions that improve lives worldwide.
* Flexibility: Hybrid working policy to balance collaboration and flexibility.
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