Help safeguard and improve product and process quality in a healthcare production environment. This 40-hour QA/RA role in Heerlen, Limburg, offers a fixed-term contract with the prospect of permanent employment.
The role
As a Quality Assurance / Regulatory Affairs Officer, you safeguard and improve product and production-process quality in a healthcare production environment. You coordinate quality assurance and control and manage the quality management system (QMS) in line with ISO 13485, ISO 9001 and applicable MDR requirements. The position is based in Heerlen, Limburg.
Responsibilities
- Manage and maintain the QMS and keep technical documentation up to date.
- Check that SOPs and work instructions comply with applicable regulations, and guide colleagues on their interpretation and use.
- Coordinate validation and qualification, including equipment calibration.
- Draft, review and approve controlled QA documents, SOPs and work instructions; maintain change control with attention to consistency, relevance and GMP compliance.
- Support corrective and preventive actions (CAPA), review their effectiveness and contribute to continuous improvement.
- Train employees, maintain training records and prepare annual reports on quality reviews and CAPA.
- Support supplier audits and the preparation of regulatory documents, including clinical evaluations, risk-management documentation, biological-safety assessments and summaries of technical documents.
- Share responsibility for the QC process, from planning and sampling through testing, analysis, documentation, reporting and traceability. Support microbiological and physical/chemical analyses of raw materials, intermediates and finished products.
- Support risk management and environmental and water monitoring, prepare trend reports, and analyze quality data and root causes of quality issues.
- Work with R&D and product teams on quality specifications for new products, monitor processes, coordinate laboratory-equipment maintenance and build constructive relationships across functions.
What you bring
- A bachelor's degree (HBO) in laboratory sciences, microbiology, chemistry or a similar field.
- At least 1–2 years of industrial QA or regulatory affairs experience in the chemical, pharmaceutical, cosmetics, biotech or a similar sector.
- Proficiency in English is required; knowledge of Dutch and German is desirable. Current knowledge of MDR, ISO 13485 and ISO 9001.
- Excellent attention to detail and the ability to meet high compliance standards; a proactive, can-do approach. You align with values such as sustainability, a maker mindset, impact, leadership and energy.
- Computer skills, including MS Office and Excel data analysis.
- Strong verbal, written and interpersonal communication; problem-analysis and problem-solving skills.
- Strong organizational skills, the ability to meet tight deadlines, and the ability to work independently and in a multidisciplinary team.
What is offered
- A fixed-term contract with the prospect of permanent employment.
- 40 hours per week.
- 29 days of annual leave based on full-time hours.
- Travel allowance.
- A pension plan and collective health insurance.
- Training and development opportunities.
- An international working environment.