Device Assembly: Quality & CAPA Specialist

Johnson Johnson; Beerse; On-site; EUR 60,000 - 90,000; Full time

Job summary

Johnson & Johnson Beerse site is seeking a Manufacturing Operations Support Specialist to lead investigations in device assembly and packaging, collaborating with QA, Engineering, MSAT and Operations to protect product quality, patient safety and supply continuity. English is required; Dutch is a plus.

This hands-on, cross-functional role has real impact on manufacturing reliability and compliance. Join a team focused on quality, CAPA, and preventive controls while working within a regulated

Qualifications

• Bachelor's or Master's degree in engineering, pharmaceutical sciences, life sciences, chemistry, or equivalent relevant experience.
• Experience in pharmaceutical manufacturing, medical devices, combination products, packaging or investigations in a regulated environment.
• Strong working knowledge of cGMP, data integrity, deviation management, root cause analysis, risk assessment and CAPA principles.
• Familiarity with automated production equipment, vision/inspection systems and packaging materials is an advantage.
• Strong analytical skills and the ability to turn complex technical data into clear, evidence-based conclusions and meet critical timelines.
• Excellent collaboration and communication skills in English (professional); Dutch is an asset for site collaboration.

Responsibilities

• Lead end-to-end investigations into deviations, incidents and complaints in device assembly and packaging to find facts and deliver clear corrective actions.
• Analyze batch records, equipment data, vision/inspection outputs, alarms and yield trends to assess product, patient and compliance impact.
• Define and drive corrective and preventive actions (CAPAs) with QA, Engineering and Maintenance to restore reliability and prevent recurrence.
• Prepare timely, cGMP-compliant investigation reports and support risk assessment, product disposition and CAPA governance.
• Turn investigation findings into durable improvements: standard work, training, procedures and preventive controls that improve right-first-time performance.
• Coach operators and teams on investigation quality, good documentation and disciplined problem solving; represent Operations in cross-functional reviews and audits.

Skills

Analytical thinking

Communication

Team collaboration

Education

Bachelor's or Master's in engineering or life sciences

Job description

Johnson & Johnson Beerse site is seeking a Manufacturing Operations Support Specialist to lead investigations in device assembly and packaging, collaborating with QA, Engineering, MSAT and Operations to protect product quality, patient safety and supply continuity. English is required; Dutch is a plus.

This hands-on, cross-functional role has real impact on manufacturing reliability and compliance. Join a team focused on quality, CAPA, and preventive controls while working within a regulated