Implementing the manufacturing build plan with subcontract manufacturer to meet device demand.
Provide technical and QA line support to the manufacturing line.
Proactive monitoring of line efficiency, performance and output
Ensure manufacturing activities are managed in accordance with the company’s quality system and policies, including diligent recording of results and writing reports.
Identify and implement opportunities for improved efficiency.
Establish new manufacturing lines and/or cleanroom space to facilitate the introduction of new product lines
Define and refine assembly methods and process settings
Periodic review of validations as required in accordance with Quality System requirements.
Completion and review of process risk analysis and ongoing dedication to risk reduction
Leading role in risk management and disaster planning.
Write procedures, protocols, specifications, and reports.
Provide design for manufacture feedback/support to R&D team during new product development phase
Maintain traceability of all finished good products
Equipment specification, procurement, calibration, and maintenance
Managing and mentoring direct reports, where relevant.
Representing the company externally, for example at physician line tours.
Liaise with component and service suppliers on delivery schedule and any quality problems