What you need to know
A leading and innovative Medical Device company in Co. Galway is currently seeking an experienced Quality Assurance Engineer to establish, implement and maintain quality systems on site.
The company are leaders in proprietary surface technologies and have been at the forefront of developing breakthrough drug delivery solutions for many of the world’s largest medical device manufacturers.
As a Quality Assurance Engineer, you will report directly to the Quality Manager on site and will work closely with R&D Engineers and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth and efficient.
This is a Permanent role with an excellent salary and package.
Your new job
Key duties & responsibilities include:
- Liaise closely with R&D and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale up are completed in a timely and cost-effective manner.
- Define and implement Quality standards and specifications.
- Participates in new product/technology development and supports the QA activities.
- Execute the project design plans, protocols and generates reports for new product development projects.
- Develop and execute required validations in line with regulatory standards.
- Conducts root cause analysis and implements corrective action in a timely
- Managing and investigating customer complaints.
- Partner with suppliers to ensure their quality standards are in line with company.
- Maintenance of an effective quality management system in compliance with applicable regulatory requirements, including ISO13485.
What are we looking for?
- An Engineering, Quality Assurance, or equivalent Science Degree (or equivalent experience).
- A minimum of three years post qualification experience in a quality function within a Medical Device or regulated environment.
- Strong knowledge of medical device quality and regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820).
- An analytical approach to problem solving.
- A good team player, who works well in a small team environment.
- Strong written and oral communication skills.
- CAPA, Auditing and Risk Management experience per ISO 14971.
- Excellent attention to detail.
- Good organisational skills and ability to track and drive activities to closure.
Benefits: Competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match and employee stock purchase plan and stock options.
Apply for this job now by sending a Word version of your CV or get in touch with Oliver at email@example.com
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