Equipment Qualification Engineer Consultant – Medical Devices

Location: Ireland & India (Initial site-based with hybrid work after initial 10 weeks)
Contract Type: Consultant
Duration:12 - 18 Months
Travel Requirement: Willingness to travel to a site in India
Pay Rate: Extremely competitive Pay Rates. 

Client: The client is in India. Initially the consultant will spend 8-10 weeks Onsite in India. After the initial 10 weeks the role will become a hybrid role where you will spend 2 weeks working in Ireland and 3 weeks in India for a period of 12 - 18 Months.

About the Role:
An exciting opportunity has arisen for an experienced Equipment Qualification Engineer Consultant to join a dynamic and forward-thinking team in the medical device industry. This role is ideal for a highly skilled professional with a proven track record in equipment qualification, particularly within Class II and III medical devices such as catheters and stents. The successful candidate will play a key role in leading teams, overseeing new equipment acquisition, and executing qualification processes on-site.

Key Responsibilities:

• Lead teams in acquiring new equipment, including equipment specification, installation, and qualification.

• Directly execute IQ, OQ, and PQ (Installation Qualification, Operational Qualification, and Performance Qualification) activities.

• Develop, review, and execute equipment qualification protocols and reports.

• Oversee the qualification of moulding tools to ensure compliance with industry standards.

• Ensure adherence to regulatory and quality requirements within the medical device sector.

• Work collaboratively with internal teams to transition towards a hybrid work model based on project progression.

Key Requirements:

• Minimum 8 years of experience in the medical device industry.

• Strong leadership experience in equipment specification, procurement, installation, and qualification.

• Proven expertise in writing and executing qualification protocols.

• Extensive knowledge of Class II and III medical devices, including catheters and stents.

• Experience in the qualification of moulding tools.

• Strong ability to work independently while collaborating effectively with internal and external stakeholders.

• Willingness to travel to the site in India for project execution.
• Silicon Extrusion experience would be highly beneficial.

Why Join Us?
This role offers the chance to work on cutting-edge medical device projects while enjoying the vibrant professional and cultural experiences of Dublin, Ireland, and India. Dublin, renowned for its thriving tech and med-tech sectors, boasts a welcoming international community and an exceptional quality of life. India, with its rapidly growing medical technology industry, provides a unique opportunity to gain hands-on experience in a dynamic environment.

If you are an ambitious Equipment Qualification Engineer looking for a challenging and rewarding consultancy role, apply today to be part of a world-class team driving innovation in the medical device sector.

For further information on this role, please contact Diarmuid Lannon on +353 861287246 or email consulting@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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