Role: Quality Engineer
Location: Can be on site in Galway or Dublin 1
Benefits: Competitive salary, yearly bonus / Share options


Company:
My client are an early stage Medical Device company working developing an innovative medical device technology to treat Benign Prostatic Hyperplasia (BPH). BPH is an enlargement of the prostate gland causing significant discomfort and affects more than 50 percent of men over 50 years of age.


Currently have 25+ employees and a management team with a proven track record of bringing innovative medical technology to market.

They are looking to expand the teams to support its development, clinical, and manufacturing activities with the recruitment of a Quality Engineer.


Role:
The candidate will report to the Quality Assurance Manager. Hands-on approach to projects with a motivated attitude and strong work ethic. An ability to work in a flexible and small entrepreneurial environment is essential. You will be working on maintaining the Quality Management System as well as work with R&D, clinical, manufacturing, and regulatory teams to ensure the device meets user, regulatory and ISO 13485 requirements.


Responsibilities:

• Development of quality plans, programs and procedures, through all aspects of the product development process.
• Assist in development of quality plans, procedures, work instructions, inspections for manufacturing process
• Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
• Ensure that performance and product quality conforms to company, customer and regulatory requirements.
• Review, analysis and reporting on quality discrepancies related to product design and manufacture.

• Assists in supporting external audits.
• Maintains quality records per applicable SOPs.
• Supports incoming inspection activities.

• Bachelor’s degree in a relevant Engineering or Science field
• 1-5 years’ experience in the medical device industry or other regulated industry

• Strong verbal, written, organizational, time management and interpersonal skills
• Strong computer skills, including working knowledge of MS Office and e-mail

• Knowledge of medical device quality systems and medical device directives (ISO13485 and FDA CFR 820)