Quality Engineer II – Manufacturing Site Transfer

About the role

Boston Scientific is looking for a Quality Engineer II to lead the manufacturing site transfer of the Cryoablation Needles Project. The role will be based in Galway and will involve coordinating quality activities between the current site in Yokneam, Israel and the new facility, ensuring compliance with global regulatory standards and patient‑safety requirements.

Key responsibilities

• Own and maintain the Manufacturing Site Transfer Quality Plan throughout the project lifecycle.
• Lead all quality‑related tasks for the site transfer, including documentation migration, bill of materials, and design documentation.
• Support qualification of the Galway cleanroom and manufacturing line, and drive equipment and process validation activities.
• Coordinate MES implementation, Guardian system requirements, and knowledge‑transfer activities between sites.
• Manage supplier and material qualification, including SIP and RBIA, and collaborate with R&D and Design Assurance on test‑method transfers.

Required profile

• Degree in Engineering, Life Sciences or a related discipline.
• Experience in medical‑device or regulated manufacturing environments.
• Proven ability to lead cross‑functional projects and work with international teams.
• Willingness to travel to Israel and other sites as needed.

Required skills

• Manufacturing Execution System (MES)
• Process validation (MVP/R, OQ, PQ)
• Equipment qualification
• Supplier qualification (SIP, RBIA)
• Cleanroom qualification
• Guardian system implementation