Senior QA Engineer: Quality Systems Lead (Hybrid)

Hollister Incorporated; Netherlands; Hybrid; EUR 52,000 - 74,000; Full time

Job summary

Hollister Incorporated in Roosendaal, Netherlands, seeks a Senior Quality Assurance Specialist to support the facility QMS and ensure regulatory compliance, product quality, and ongoing process improvements.

The role leads quality projects, audits, and risk assessments, collaborating with Operations and Global Quality to align documentation, training, and decisions with company quality objectives. The position operates in a hybrid work environment with 4 days on-site.

Qualifications

• 5–8 years in a quality role within GMP/GDP regulated pharma/medical device industry.
• Experience in audits, CAPA, change control, and risk assessment.
• Ability to write clear technical reports and quality documentation.

Responsibilities

• Apply advanced knowledge of medical device quality systems to support compliant facility operations.
• Lead or support site‑specific QMS processes, records, and training.
• Prepare for audits and provide evidence of compliance.
• Provide quality input on material disposition, process controls, and CAPA activities.
• Present complex quality information clearly to stakeholders and regulators.

Skills

Quality Assurance

Quality Systems

Cross-functional collaboration

English & Dutch

Project Management

Education

Bachelor's degree

Tools

QMS software

Documentation control systems

Job description

Hollister Incorporated in Roosendaal, Netherlands, seeks a Senior Quality Assurance Specialist to support the facility QMS and ensure regulatory compliance, product quality, and ongoing process improvements.

The role leads quality projects, audits, and risk assessments, collaborating with Operations and Global Quality to align documentation, training, and decisions with company quality objectives. The position operates in a hybrid work environment with 4 days on-site.