QA Design Officer

QTC are partnered with a growing speciality medical device company creating and manufacturing a class III product via an aseptic process within the aesthetic specialism. Products are designed and produced in-house before being distributed through a global network of suppliers. The business are experiencing continued growth and are looking for a new member to join their quality and regulatory function.

Our client are searching for a technical QA/RA Design Specialist to join their team on a permanent basis. The role will focus on owning the technical file process including leading relevant updates based on MDR, maintaining documentation history and controlling suppliers of technical file activities. Additional activities will include: Providing international regulatory support throughout the product life cycle. Presenting and defending technical documentation during regulatory inspections. Complaint handling and root cause investigations. Handling risk assessments along with project/change management.

Requirements:

• You hold at least a bachelor's degree in a technical or medical field
• Relevant experience in the medical device of pharmaceutical industry
• Extensive knowledge of MDD and MDR.
• Possess strong technical writing and communication skills
• Working command of English language
• Experience working within smaller cross-functional teams beneficial

Offer:

• Varied and dynamic role in a growing organisation
• Competitive basic salary with additional benefits
• 13th month bonus
• Transferrable experience in a highly regulated class III environment