Job title: Design Assurance Program Manager
Location: Ballybrit Upper Industrial Estate, Galway
Benefits: Hourly rate contract, 3 days a week (Partime), Hybrid working
Company:
My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and component technologies.
Responsibilities:
• Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation. Providing detailed planning for clinical, pilot production and scale-up plans in New Product Introduction programs.
• Ensuring project teams are utilizing Nordson Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
• Investigating and evaluating material biocompatibility and appropriate methods of sterilization during the product design cycle.
• Conducting risk assessments of the design to determine ability to function as intended.
• Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
• Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.
• Intervening and contributing to successful resolution of technical issues when they arise.
• Ensuring that all work satisfies the requirements of the company's Quality Manual.
• Continually looking for improvement and compliance improvement opportunities.
• Leading Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
Skills and Qualifications:
• Minimum Bachelor's degree in Engineering or related field.
• 6+ years of medical device design and development/quality assurance experience is required.
• Managing customer relationships and responses in aa timely manner.
• Ability to interact with client companies in a professional manner.
• Demonstrated ability to lead product verification & validation activities
• Experience working with operations to develop strong manufacturing process instructions and operator training is desired.
Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie