Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site on a contract basis.
- Fulfil the quality assurance responsibilities of the company's product development and related sustaining engineering activities, including:
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in the company.
- Understanding and complying with the company's 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 the company's devices.
- Ensuring their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- 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 the company, Galway 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
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