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Advancing possibilities for a brighter tomorrow
We are seeking a Quality Engineer II on a permanent basis to join our team. The shift for this position is (Insert shift and times).
Job purpose
We are seeking a Quality Engineer II (Lateral Move) to support the Cryoablation Needles Project within the AMT Product Unit. In this role, you will lead and execute quality activities associated with a strategic manufacturing site transfer, ensuring compliance with Boston Scientific quality systems and global regulatory requirements. You will collaborate across manufacturing, operations, research and development, suppliers and international partners to ensure a successful technology transfer while maintaining the highest standards of patient safety and product quality.
The Cryoablation Needles Project supports the transfer of manufacturing for Galil Medical Cryoablation Needles. These sterile, single-use medical devices are used with the Galil Medical Cryoablation System to deliver minimally invasive cryotherapy through controlled freezing and thawing cycles for the treatment of cancerous tissue.
The current manufacturing site is located in Yokneam, Israel. You may be required to travel to the Yokneam site during 2026 to support knowledge transfer activities and periodically thereafter as part of the role.
Key responsibilities
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Own the Manufacturing Site Transfer Quality Plan and maintain it throughout the project lifecycle.
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Lead all quality activities associated with the manufacturing site transfer.
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Coordinate documentation transfer activities, including manufacturing instructions, bills of materials, routers, Manufacturing Execution System (MES), process risk assessments, design documentation, product release documentation, MIO activities, sterilization documentation and regulatory submissions.
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Support the establishment and qualification of the Galway cleanroom and manufacturing line.
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Partner with manufacturing leaders to develop and execute training activities.
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Lead process validation activities, including MVP/R, OQ, PQ and process performance assessments.
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Implement Guardian system requirements.
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Support equipment qualification activities.
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Lead supplier and material qualification activities, including SIP and RBIA.
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Partner with Design Assurance and Research and Development teams to complete test method transfers.
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Support workstation validation activities.
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Lead Manufacturing Execution System implementation activities.
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Coordinate knowledge transfer activities between Galway and Yokneam.
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Support production and process control implementation.
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Establish facility, environmental monitoring and microbiological control activities.
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Support finished goods acceptance, handling and distribution quality controls.
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Partner with the Yokneam site during manufacturing decommissioning activities.
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Proactively identify and mitigate quality risks throughout the project.
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Ensure project milestones are delivered on schedule through effective planning and prioritization.
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Communicate technical information clearly to cross-functional stakeholders.
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Promote continuous improvement through lessons learned and best practices.
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Ensure compliance with Boston Scientific Quality Systems, ISO standards and applicable medical device regulations.
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Apply risk management principles throughout design transfer and manufacturing activities.
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Support change control activities as both a change owner and quality approver.
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Evaluate new equipment, processes and materials with Environmental Health and Safety.
Education & experience
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Level 8 Hons Bachelor Degree (or higher) in Engineering or related field
- Minimum of 2 years' experience in quality engineering within the medical device or another highly regulated manufacturing environment.
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Experience supporting manufacturing transfers, process validation or technology transfer projects.
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Knowledge of quality management systems and applicable regulatory requirements.
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Experience with process validation, equipment qualification and change control.
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Knowledge of risk management principles and quality documentation.
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Experience working with Manufacturing Execution Systems.
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Strong analytical, organisational and communication skills.
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Knowledge of sterile medical devices and sterilization processes desirable.
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Experience working with Design Assurance and Research and Development teams.
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Supplier quality or materials qualification experience desirable.
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Lean, Six Sigma or continuous improvement experience desirable.
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers and communities we serve.
Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [email protected].
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