Quality Assurance Specialist

Quality Assurance Specialist

Perrigo

Nazareth, Belgium

Scope of the Role

The Quality Assurance Specialist is in charge for Perrigo marketed products of

• Product complaint management: dispatch, handle and close complaints in a timely manner. Build a relationship with all stakeholders involved in the complaint flow and ensure mutual support
• Medical Device Batch release activities: timely release batches to meet the needs of the business while ensuring that all quality aspects are covered. Become proficient in the use of the ERP system
• Support to trending activities: support the QA department in the preparation of reports and trend analysis. Own sections of the monthly trend analysis
• Support to QMS activities: support the team in the preparation of the management review. Actively participate in the maintenance of the QMS

Main Activities

Product complaint management

• Registration and handling of product quality complaint
• Review and analysis of data coming from internal (TW) and external databases
• Support the improvement and harmonization of the complaint management

Medical Device Batch release activities

• Release products in line with regulatory requirements and internal procedures
• Work in the ERP system
• Coordinate quarantine shipments and ensure correct release of products shipped under quarantine
• Support the improvement and harmonization of batch release activities

Perform trending analysis

• Collect and analyse data used in trending analysis
• Support the creation of monthly reports
• Provide inputs for the preparation of management review

Support to quality activities performed at PERRIGO

• Creation and revision of quality documents
• Participate in the coordination of batch recall
• Coordinate the rework/relabelling activities for Medical Device and Cosmetic products
• Ensure timely closure of CAPA, deviations and non-conformities
• Support the QA department with general administration work and ad hoc duties as they arise

Experience Required

Scientific background

• Ideally, 1-2 years in quality assurance in a Medical Device/Pharmaceutical environment
• Basic knowledge of ISO13485 and MDR
• Good IT knowledge and skills
• Self-starter, capable of working autonomously at corporate level
• Clear communicator, practical and solution orientated
• Enthusiastic and get the job done
• Strong project management skills & team worker in a multicultural environment
• Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills
• You speak and write fluently English; other languages are an asset
• An innovative frame of mind – open to applying creative techniques to find a solution

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