Job Title: Design Assurance Program Manager
Location: Galway
Responsibilities:
* Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation.
* Ensuring project teams are utilizing Quality Systems and 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.
* Intervening and contributing to successful resolution of technical issues when they arise.
* Ensuring that all work satisfies the requirements of the 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 a 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.
Benefits:
This role offers the opportunity to take on a challenging leadership position and contribute to the development of high-quality medical devices.
Others:
The ideal candidate will be a strategic thinker with excellent communication skills, able to effectively collaborate with cross-functional teams to drive quality initiatives forward. They will possess strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.