Due to continuing expansion and business growth, our client is seeking applications for Quality/Documentation Control Assistant – Medical Device to join their manufacturing function. Based in Shannon Ireland, this role offers a fantastic career opportunity for suitable qualified applicant.
Purpose of the Role
The Quality/Documentation Control Assistant is the key role to support the Key Account Manager in the manufacturing and order fulfilment of Medical Diagnostic kits. Primary focus of this role is to continuously manage and improve the existing operations while being able to support and direct the day to day manufacturing and logistics activities in this fast-growing industry.
Responsibilities:
• Create the monthly production plans from Client forecasts
• Calculate and execute the weekly/daily production schedules
• Develop the production planning process in line with Lean principles
• Update and maintain GMP documentation for the process activities
• Ensure that capacity, capabilities, and systems are in place to execute reliable cost-effective manufacturing of kits
• Evaluate the manufacturing metrics and performance indicators
• Supervise the efficient implementation of product and process changes
• Support the development and start-up of NPI’s securing raw materials and packaging
• Liaise with QA on customer complaints, CAR’s and non-conformances
• Maintain the manufacturing processes to the ISO 13485 standards
• Support the troubleshooting activities and investigate
Education & Competencies:
• Bachelor’s Degree ideally in Science or similar
• Previous experience minimum 1 to 2 years in similar regulated (13485) production environment
• Ability to lead/execute projects with strong written/oral communication skills
• Enthusiastic and energetic with the ability to integrate quickly into a team environment
• Demonstrated flexible and innovative approach to work
• Ability to work on own initiative and in an organised manner
• Meticulous attention to detail.
• Interest in learning & developing in a busy supply chain environment
• Excellent IT literacy and knowledge of Excel/ MS PBI/Excel / ERP systems
• Experience in quality systems ISO 13485 significant advantage.
eFlexes is an equal opportunities employer
