Our client is looking add a design assurance engineer to their post market sustaining team. This is an excellent opportunity to work with a leading name in the medical device industry in Galway city.
Location - Galway
Length of contract - 12 Months
Hybrid role with 3/4 days onsite and 1/2 days from home
- 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.
- Completes work assignments under limited supervision/guidance.
- Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centers 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 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 sustaining engineering 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
- 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.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. For further information on this role please contact Emma 086 0334325 /firstname.lastname@example.org
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