About Your New Employer:
This Employer is a global manufacturer of the innovative non-invasive cardiovascular devices, well established in the West of Ireland for the last decade. The company is passionate about promoting inclusive and friendly work culture, as well as providing great opportunities for development.
About Your New Job as a Design Assurance Engineer II:
- Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
- Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
- Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
- Continually seeks to drive improvements in product and process quality.
- Implement, maintain and update procedures that ensure that R&D documentation constantly meets Product Development Process and Design Control requirements.
- Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
- Support internal and external audits.
- Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
- Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
- Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements
- Build Quality into all aspects of work by maintaining compliance to all quality requirements.
- Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.
What Skills You Need to succeed as a Design Assurance Engineer II:
- Level 8 Bachelors Degree (240 credits) in STEM (Quality, Science or relevant discipline)
- 3+ years experience in a similar role
What’s on Offer for Candidates for a Design Assurance Engineer II:
- Salary of 47k – 57k
- Benefits package: Bonus, healthcare, life assurance, pension
- Fantastic career development opportunities
What’s Next
- Apply now by clicking the “Apply Now" button or call me, Karolina on +353 091749267.
- Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.