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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Courcelles, Hainaut, Belgium
Job Description:
Lead Quality – Qualification & Validation (Distribution Center) Location: Courcelles (EMEA) — Hybrid (3 days onsite / 2 days remote) Contract: CDI / permanent contract
Join a high‑impact Quality team at a global MedTech leader and own the technical delivery of equipment qualification & validation at a strategic European Distribution Center. This is a hands‑on, visible role where your expertise in IQ/OQ/PQ, process qualification and operational quality will directly improve patient safety, reduce regulatory risk and raise operational excellence across repack/relabel and distribution activities.
What you will do (core responsibilities)
- Lead and coordinate qualification, validation and calibration activities for equipment and facilities used in distribution and repack/relabel operations (new equipment qualification and periodic re‑qualification).
- Act as the operational Quality expert on the floor: Gemba walks, weekly operational kick‑offs and direct coaching of warehouse teams.
- Drive and follow up internal & external audits and inspections; perform proactive gap analyses and implement CAPAs to secure business continuity.
- Own Change Control activities related to DC and repackaging processes and ensure robust documentation and approvals.
- Maintain and improve QMS elements: SOPs, Work Instructions, document control, training, CAPA, investigations and KPI tracking.
- Analyze NC/CAPA and delivery service trends, propose corrective/preventive actions and feed the Quality Improvement Plan (QIP) and Quality System Management Review (QSMR).
- Participate in cross‑functional projects (new equipment, process automation), ensuring validation and regulatory requirements are met.
- Identify, assess and mitigate quality risks tied to QA and operational processes.
Who we are looking for (must‑have profile)
- Proven experience in a regulated environment (pharmaceuticals, medical devices or healthcare operations) with a clear focus on QUALIFICATION & VALIDATION of equipment and facilities.
- Demonstrated track record executing IQ/OQ/PQ protocols, preparing validation dossiers and leading equipment requalification programs.
- Strong knowledge of quality system processes: Change Control, CAPA, Investigations, Document Management, Training and Audit.
- Familiarity with GDP/GMP requirements and ISO 13485.
- Analytical mindset, risk‑based approach, excellent written & verbal communication, ability to influence cross‑functional stakeholders.
- Able to work independently, organize priorities and escalate appropriately.
Technical tools & experience (advantageous)
- Experience with JDE, ETQ (or equivalent QMS), Windchill, Summit or similar systems.
- Strong Excel and Microsoft Office skills.
- Lean/process improvement experience is valued.
Languages
- English only is sufficient to apply.
- French is a strong advantage (local interactions & documentation).
Remuneration & benefits
- Indicative base salary: €60,000 – € 96,255 gross per year (depending on experience).
- Comprehensive J&J benefits package: performance bonuses, health and pension benefits, local employee benefits (e.g., meal vouchers / mobility allowances where applicable / internet allowance /eco-cheques / leisure cheques).
- Career development and international mobility opportunities within the EMEA network.
Working arrangement
- Hybrid: 3 days onsite at Courcelles / 2 days remote per week.
- Close collaboration with Operations, Supply Chain and EMEA Deliver teams.
Why join us
- High visibility role with direct impact on compliance, safety and operational efficiency.
- Blend of technical validation work, process ownership and cross‑functional project delivery.
- Opportunity to shape best practices on Qualification and Validation processes
**Required Skills: **
Preferred Skills: