ROLE / RESPONSIBILITIES

• Quality Management; management of SOPs, WI, etc and compliance with these specifications, organise and oversee training programs, participation in both internal and external audits
• Qualification and Validation; creating and maintaining the Qualification/Validation Master Plan, supporting the creation of User Requirements Specifications and Design Specifications, carrying out risk analyses (FMEA), IQs, OQs and PQs
• Quality Planning; Planning, coordinating and monitoring all quality-assurance measures, creating and maintaining inspection plans/instructions/schedules
• Complaint Handling; Ensuring proper complaint recording, implementation and control of the root cause analysis and evaluating complaint statistics
• Continuous improvement; identification of improvement potential on existing products and processes, planning, coordinating and monitoring improvement measures

REQUIREMENTS

• Minimum 3 years' experience in a relevant quality role.
• Relevant scientific or engineering degree
• Medical device experience preferred
• Advanced interpersonal and communication skills, strong people & business leadership skills.
• Ability to effectively manage multiple projects and priorities.
• Strong analytical, planning and problem-solving skills.
• Demonstrated skills in MS-Office suite, Adobe, and SAP.
• Able to work independently under minimal supervision.
• Able to efficiently communicate and collaborate amongst a team, people management experience preferred.