Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site.
- Completes work assignments under limited supervision/guidance.
- Interfaces with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing in a project team environment providing technical and Quality systems input to the team.
- Familiarity with requirements and procedures that govern the Product Development Process and Design Control requirements.
- 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. Participates in the company's internal audit program.
- Excellent interpersonal and communication skills with good leadership abilities.
- Provides both quality and technical input to the design reviews, project development/ design change/recertification plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
- Experienced in validation techniques, risk management, statistical techniques and compliance to regulatory requirements. Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
- 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.
- Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.
- Is an active team member completing quality deliverables associated with the company's product development and sustaining engineering projects.
- Coaches others in areas of expertise. Gives technical guidance to Design Assurance Engineer I, Graduate Design Assurance Engineer and Design Assurance Technicians.
- Is a good team member, fully motivated to achieve and demonstrate best practices in line with the project, department and site objectives.
- Supervision and development of staff reporting to them in line with departmental and project goals.
- Uses opportunities in project assignments to develop self & other team members.
- Provides guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with Corporate and company SOP's
- Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.
- HETCA Level 8 in a relevant area with a minimum of 5 years' experience in a similar environment.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own with minimum supervision
For further information on this Design Assurance Engineer role in Galway please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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