Leading Medical Device organisation in Galway seeking an experienced Design Assurance Engineer
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality
- Understanding and complying to the company’s quality, business, health & safety systems and market/legal regulations governing the quality systems.
- Removing or mitigating against risks associated with the design, use and manufacture of company devices.
- Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.
- Completes work assignments under limited supervision/guidance.
- Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres 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.
- Identifies and resolves complex exceptions to work assignments.
- Seeks to support improvements in product and process quality.
- Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
- Excellent interpersonal and communication skills with good leadership abilities.
- Provides both quality and technical input to ongoing product development and post-market commercial product activities.
- Experienced in post-market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
- Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
- Excellent analytical and problem-solving abilities. Analyses draws conclusions and makes appropriate decisions from risk management activities and test data.
- Is an active team member completing quality deliverables associated with the company’s new product development and post-market (commercial product) support.
- Coaches others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others.
- Is a fully motivated team member – achieves and demonstrates best practices in line with set objectives.
- Is willing to implement changes within the project/department practices and supports 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
- Salary DOE
- Full Healthcare
Please get in contact on firstname.lastname@example.org for more information