Design Quality Assurance Engineer Role
Job Summary:
We are seeking an experienced Design Quality Assurance Engineer to join our team in Galway. As a member of our quality assurance group, you will play a key role in ensuring product quality, safety, and effectiveness.
Key Responsibilities:
* Develop and implement quality documentation, including design control processes and design history files.
* Provide guidance to project teams on the utilization of Medical Quality Systems and industry standards throughout the product development process.
* Conduct risk assessments of designs to determine ability to function as intended.
* Ensure 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.
* Audit and qualify new suppliers, and interact with customer and supplier companies in a professional manner.
* Lead 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.
Requirements:
* Bachelor's degree in Engineering or related field.
* Minimum 3 years of medical device design and development/quality assurance experience.
* 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 is desired.
* Familiarity with FDA QSRs, medical device regulations, and ISO 13485.
Benefits:
* Top salary.
* Pension.
* Healthcare.
* Yearly bonus.
* 4 day week.
This is a dynamic and collaborative environment where your ideas and contributions will be valued and respected. We offer a competitive compensation package and opportunities for growth and development. If you are a motivated and experienced professional looking for a challenging role, please apply today.