Sr Quality Systems Engineer (Cartago)

Boston Scientific

Cartago Province, Cartago

About the role :

Provide Quality Engineering and Quality Process support at early stages of BSC Cartago West Green Field site. Establish, develop, and maintain procedures related to different elements of the Quality Management system to meet regulatory requirements, corporate policies, internal policies, and business needs.

Support product transfer activities. After transfer provide support as part of sustaining mode to manufacturing, helping to ensure delivery of highest quality product to the customer.

This is a key role to prepare the manufacturing site to host successful inspections by competent authorities like FDA and external Audits by Notify Bodies (some products contain Material of Animal Origin and require Premarket Approval).

Your Responsibilities Include :
• Ensure that BSC Costa Rica is in compliance with Corporate and Regulatory Requirements at all times.
• Develop continuous improvements initiatives of the Quality System of BSC Costa Rica.
• Participate & support... More Detail

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