Quality Engineer Medical Device Manufacturing
2 days ago
JO-2503-549234
Quality Engineer - Kildare
Quality Engineer Medical Device production in Kildare
Cpl are supporting our client partner who are global leader on Outsourcing Contract Manufacturing to most of the heritage brands across the global medical device and sterile injectable products store.
To support rapid growth for 2025 and onwards, they are now looking to recruit a Quality Engineer to join their Quality Operations team.
Reporting to the site Head of Quality and Operations, you will be a core member of a team of Quality Engineers supporting the ongoing and rapidly expanding medical device program on the site in North Co. Kildare.
The company are in the process of increasing their headcount by an additional 25% this year.
The new Quality Engineer role is going to be a particularly exciting new opportunity.
The company have just completed the installation and commissioning of a new high volume production line, and this line has been installed for a new medical device manufacturing contract.
Overview of Role:- Support the ongoing development of the Quality Engineering function for the plant through the identification and introduction of new world class techniques and technologies.
- Liaise with Automated Production & Engineering to ensure that the goals, targets, and objectives of the group are continuously met.
- Represent, provide the expertise and support to all aspects of the company's operations on quality issues.
- You will be a site Subject Matter Expert for investigating productivity issues, product, plant or material deviations and liaising directly with external suppliers as well as all other stakeholders in the manufacturing process onsite.
- You will support the Production line areas for quality and material issues as required.
- The Quality Engineer will closely work with partners across the value chain for process, quality and cost improvements projects.
- It's essential that the Quality Engineer will be a Key Productivity Team contributor, coaching team members and introducing lean concepts to enable identification of opportunities for improvements.
- As the Quality Engineer, you will be tasked with review and approval of deviations, change controls, SOPs, out of specification compliances, lab or testing investigations.
- The Quality Engineer will take a leadership role for internal audits and ongoing reviews of manufacturing operations and the sites quality systems to ensure they comply with GMP and other internal and external regulations.
- Participate in the development of the Quality Engineering function for the plant through the identification and introduction of new world class techniques and technologies.
- Work as part of the quality team in the overall support/service of the manufacturing operation, through the introduction of new technology/techniques, skill development, training, process optimisation and cost saving projects.
- Provide specialist quality and technical engineering support to all departments.
- Ensure the maintenance, management and development of our Quality Management System.
- Lead and participate in cross-functional teams & process improvement initiatives.
- Further develop our Quality Lab resource in line with product qualification and inspection demands.
- Ensure validation and qualification of all new and existing products, equipment and processes.
- Participate and actively engage the company's programme to help achieve and maintain an "Improve Everyday" Culture.
- Proactively participate in the Performance Management process to ensure delivery of own, and the wider team's objectives.
- Demonstrate a strong positive work ethic that will embody the company's culture and corporate values.
The ideal candidate for this Quality Engineer role will hold at least the following:
- If you have experience with ISO13485 that would be a major advantage.
- BSc in Engineering, Quality Systems Management or other related field of expertise.
- A minimum of 3 years in Medical Device, Food and or Beverage production or pharmaceutical manufacturing product development, quality control and/or cGMP compliance.
If you're interested in a career with a progressive dynamic and rapidly growing company specialising in the manufacture of medical device equipment and you are committed to working on-site Monday to Friday in North Kildare, then please send me your CV to shane.gleeson@cpl.ie.
I'll review the CV and reply to you within 24 hours.
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