Senior Qaulity Specialist OTC/Medical Devices

Senior Qaulity Specialist OTC/Medical Devices

Perrigo

Ghent, Belgium

Scope of the Role

You will lead a team of people (up to 8 people).

The team is representative within product categories and responsible for all QA matters associated with these:

• Act as quality representative in product related category meetings
• Prepare and maintain Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors)
• Assist with due diligence and integration of new product developments / new product introductions
• Support technical transfers, qualification and validation work
• Participate to Change control process for the related Products and follow-up implementation of changes
• Support in stability programs and review of stability results
• Support QA activities in data and document collection for regulatory purposes, including but not limited to maintenance of technical files
• Provide input to risk management plan and risk management file in line with ISO14971
• Perform and support technical assessments of products, processes and documentation

Ensure compliance to design and development of medical devices:

• Support during day-to-day operations (batch release of MD, complaint investigation, rework, Quality Management improvement activities)
• Keep going awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD)
• You will also ensure the effective investigation (including non-conformity handling) of complaints and other incidents, including root cause analysis and defining CAPAs for short term and long term improvements
• You will be maintaining databases and documents according to good documentation practices and record retention procedure
• You will support internal and external audits

Experience Required

• Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry … or equivalent through experience
• Minimum 3 to 5 years of experience in quality assurance
• Good knowledge of the relevant European regulations (MDR, ISO 13485, GMP,…)
• You are a self-starter, capable of working autonomously at corporate level
• You are a clear communicator, practical and solution orientated
• You are enthusiastic and hands-on
• You have 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 are fluent in spoken and written English. Other languages are an asset

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Belgium      Medical Devices      Quality Assurance      Perrigo