Quality Engineer II – CAPA, Training & Doc Control

Boston Scientific Corporation; Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

Boston Scientific Corporation in Cork is seeking a Quality Engineer II to maintain and improve the Quality Management System, ensuring compliant documentation, training, and CAPA processes. You will partner with cross-functional teams to drive quality excellence and operational performance on site.

You will lead document control, training administration, and quality records management, while supporting periodic reviews and continuous improvement initiatives to strengthen the quality culture

Qualifications

• Level 8 Hons Bachelor Degree (or higher) in Engineering, Science, Quality, or a related discipline.
• Experience working within a regulated manufacturing, pharmaceutical, medical device, biotechnology, or similar environment would be advantageous.
• Experience working with Pharmaceutical Quality Management Systems and quality documentation.
• Knowledge of CAPA, change control, document control, training systems, and quality records.
• Experience with electronic Quality Management Systems; MasterControl experience would be highly desirable.

Responsibilities

• Lead the implementation of assurances, documentation control, training support and CAPA systems designed to meet or exceed internal and external requirements.
• Maintain effective control of pharmaceutical quality documentation within MasterControl.
• Create, issue, revise, archive, and retrieve controlled documents in accordance with established procedures.
• Support the administration and maintenance of employee training requirements.
• Create and manage training roles and assignments within the applicable training system.
• Support the induction and training requirements for new employees.
• Review training items, CAPAs, and other quality-related training requirements.
• Ensure MasterControl job codes and training plans are appropriately aligned.
• Support the development and maintenance of training courses, job codes, examinations, and other competency assessment materials.
• Manage and support the Quality events and CAPA process, including tracking actions through to timely completion.
• Support periodic quality reviews and identify opportunities for improvement.
• Support the investigation, documentation, and closure of quality issues and CAPAs.
• Support periodic quality reviews and identify opportunities for improvement.
• Participate in continuous improvement activities across Quality Systems.
• Users of this printed copy must verify that this document is current.
• Review and implement relevant global Quality System updates and assess their impact on site processes.

Skills

CAPA knowledge

Document control

Training systems

Quality records

Education

Bachelor degree in Engineering/Science/Quality

Tools

MasterControl

Job description

Boston Scientific Corporation in Cork is seeking a Quality Engineer II to maintain and improve the Quality Management System, ensuring compliant documentation, training, and CAPA processes. You will partner with cross-functional teams to drive quality excellence and operational performance on site.

You will lead document control, training administration, and quality records management, while supporting periodic reviews and continuous improvement initiatives to strengthen the quality culture