Senior Quality Specialist (Medical Devices)

Job Requirement:

• Understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Understanding of processes and equipment used in assigned work
• Excellent documentation and communication skills and interpersonal relationship skills
• Expert understanding of manufacturing process/procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• Experience writing and executing protocols for validation of tools, fixtures, equipment, and process.
• Ability to perform root cause analysis and recommendations. Capable of making decisions based on data, analysis, and problem-solving methods
• Knowledge and adherence to applicable regulatory requirements (e.g., ISO 13485, ISO14001)
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Communications ability in English for presentations, written documents, and verbal. The ability to communicate to senior management, peer levels, and subordinate levels of the organization in a clear, concise, and accurate manner.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Prior medical device experience is preferred