Job Title: Quality Assurance Specialist
Location: Galway, Ireland
Benefits:
* Top salary and benefits package
* Pension scheme and healthcare plan
* Yearly bonus and 4-day week
Company Overview:
We are a global expert in the design, development, and manufacturing of complex medical devices.
Role Overview:
This is an exciting opportunity to join our team as a Quality Assurance Specialist, where you will be responsible for ensuring the quality of our products.
Responsibilities:
1. Lead Quality Engineer on projects, providing guidance to others to establish quality documentation.
2. Provide detailed planning for pilot production and scale-up plans in New Product Introduction programs.
3. Ensure project teams are utilizing Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
4. Conduct risk assessments of the design to determine ability to function as intended.
5. 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).
6. Interact with customer and supplier companies in a professional manner; proactively communicate with them to ensure an ongoing two-way exchange of information.
7. Auditing and qualification of new suppliers may be required.
8. Intervene and contribute to successful resolution of technical issues when they arise.
9. Ensure that all work satisfies the requirements of the company's Quality Management System.
Required Skills and Qualifications:
* Minimum Bachelor's degree in Engineering or related field.
* 3 years of medical device design and development/quality assurance experience.
* Manage 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.
About Us:
We value our employees and strive to create a positive and supportive work environment.