Design Assurance Engineer
CREGG Recruitment are currently hiring a Design Assurance Enigneer to work onsite with a leading medical device multinational client in Galway. 39 hour week. This is an initial 12 month contract with good potential for an extended contract. For more information on this role call Stephen Coen 0861030418 or Email stephencoen@cregg.ie
About the Job:
This role will be based in a busy New Product Introduction Department – previous experience in a similar role with a design background is preferable.
Role Responsibilities:
- 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.
- 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 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.
Key Requirements:
- Level 8 Degree STEM discipline
- Previous 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.