Design Assurance Engineer
We are currently working with a world-renowned medical device company based in Galway who have several excellent opportunities for experienced Design Assurance Engineer's to join a team on both Permanent and Fixed Term contracts. Successful candidates will be required to fulfil the assurance responsibilities for product development.
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
- Understanding and complying to quality, health & safety systems and market/legal regulations governing the quality systems.
- Removing any risks associated with the design, use and manufacture of medical devices.
- Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.
- Complete work assignments under little supervision/guidance.
- Have good knowledge of R&D, Regulatory Affairs, Clinical, Medical Safety, and Post Market Quality Assurance team environment providing technical and quality systems input.
- Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
- Identify and resolve complex exceptions to work assignments.
- Seek to support improvements in product and process quality.
- Maintain compliance to all quality requirements.
- Show excellent interpersonal and communication skills with good leadership abilities.
- Provide both quality and technical input to ongoing product development and post market commercial product activities.
- Always provide design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
- Excellent analytical and problem-solving abilities. Draw conclusions and makes appropriate decisions from risk management activities and test data.
- To be an active team member completing quality deliverables associated with BSC's new product development and post market (commercial product) support.
- Coaching: Give technical guidance to junior team members. Use opportunities in project assignments to develop self & others.
- Be a fully motivated team member - achieve and demonstrate best practices in line with set objectives.
- Implement changes within the project/department practices and support a culture of challenging the status quo to create best in class.
Qualifications & Experience:
- HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 3-4 years' experience in a similar role.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own with minimum supervision
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.