Job title: Design Assurance Program Manager
Location: Ballybrit Upper Industrial Estate, Galway
Benefits: Hourly rate contract, 3 days a week (Part-time), Hybrid working
Company:
My client is a global leader in the medical device industry and an expert in the design, development, and manufacturing of complex medical devices and component technologies.
Responsibilities:
1. Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation. Provide detailed planning for clinical, pilot production, and scale-up plans in New Product Introduction programs.
2. Ensure project teams are utilizing Nordson Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
3. Investigate and evaluate material biocompatibility and appropriate methods of sterilization during the product design cycle.
4. Conduct risk assessments of the design to determine the ability to function as intended.
5. Be 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.
6. Interact with customer and supplier companies in a professional manner; proactively communicate with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.
7. Intervene and contribute to the successful resolution of technical issues when they arise.
8. Ensure that all work satisfies the requirements of the company's Quality Manual.
9. Continually look for improvement and compliance improvement opportunities.
10. Lead Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes, or products to bring concepts to market, including essential product and process documentation.
Skills and Qualifications:
1. Minimum Bachelor's degree in Engineering or related field.
2. 6+ years of medical device design and development/quality assurance experience is required.
3. Manage customer relationships and responses in a timely manner.
4. Ability to interact with client companies in a professional manner.
5. Demonstrated ability to lead product verification & validation activities.
6. 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 at 087 0612325 OR thomas.gallagher@lifescience.ie
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