Quality Engineer II

Boston Scientific; 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

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

Boston Scientific is seeking a highly motivated Quality Engineer II on a permanent basis to join our Cork team .

Job Purpose:

The Quality Engineer will play a key role in supporting, maintaining and continuously improving the Quality Management System (QMS) to ensure effective quality processes, accurate documentation, training compliance and adherence to applicable regulatory requirements and company standards.

In this role, you will collaborate with cross-functional teams to drive quality excellence through corrective and preventive action (CAPA) activities, document control, change management, quality records management and continuous improvement initiatives. You will also provide day-to-day quality support, identify opportunities for process improvement and help strengthen a culture of quality, compliance and operational excellence across the site.

Key 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.

Education & Experience:

• 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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognise 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 [e-mail]

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Quality Engineer, Document Control, Manufacturing Engineer, Medical Device Engineer, CAPA, Engineering, Administrative, Management