Design Assurance Engineer II
This role is with a Multinational Medical Device company based in Galway. For further details please contact Michelle on 086 608 6644.
Fulfil the quality assurance responsibilities of new product development and post-market (commercial product) support, including:
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
- Understanding and complying to 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 Medical 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 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.
- The majority of the work will be spent on-site in an office environment with occasional requirements to work in a test lab/cleanroom environment
- There may be a requirement as part of the role to travel to other sites
Qualifications & Experience
- HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 3 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.
Please contact Michelle at 086 608 6644 for more information.