Atlantach Technical Services is an Engineering solutions company specialising in the project management, construction and commissioning market in Ireland and the USA. We are a trusted partner to leading blue chip companies across many sectors with project work spanning semiconductor, automotive, MedTech and Data Centre – just some of the focus areas we work in.
Join Our team
Currently, we are looking for like-minded professionals to join our team and are hiring a Design Assurance Engineer to support our very high-profile Medical Device client in Co. Galway.
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 devices.
- Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.
Duties and Responsibilities:
- 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
- HETAC Level 8 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
- Good verbal and written communication skills
- Strong analytical skills
- Comfortable working independently and as part of a cross-functional team
- Prior medical device industry experience
Atlantach Technical Services is an Equal Opportunities Employer