Our client, a medical device company in Galway is currently looking to recruit a Senior Design Assurance Engineer for their site.
Fulfil the quality assurance responsibilities of the company’s product development and related sustaining engineering activities, including:
- Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in BSC.
- Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
- Promoting and effecting compliance to BSC’s quality, business and health & safety systems and market/legal regulations.
- Analysing, reducing and managing risks associated with the design, use and manufacture of BSC devices.
- Providing expertise in BSC’s product development systems to project teams
- Supervising, leading and coaching members of the design assurance department
- Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
- Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
- Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
- Continually seeks to drive improvements in product and process quality.
- Implement, maintain and update procedures that ensure that R&D documentation constantly meets BSC’s Product Development Process and Design Control requirements.
- Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
- Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
- Identifies and resolves complex exceptions to work assignments.
- Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
- Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements
- Build Quality into all aspects of work by maintaining compliance to all quality requirements.
- Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group. Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in BSC’s Product Development Process (PDP), Recertification, Risk Management and Design Control SOPs
- Co-ordination of team activities in line with departmental objectives and project goals.
- Supervision and development of staff reporting to them in line with departmental and project goals.
- Uses opportunities in project assignments to develop other team members.
- Coaches others in analysis and decision making. A source of technical guidance to Quality Engineer II, Quality Engineer I, Graduate Quality Engineer, Technician and Inspection staff.
- Is perceived as a proponent of change within the project/department and willing to challenge the status quo to create best in class.
- Is a good team member, committed to the project’s success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives?
- Provide guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with BSC policies and procedures.
- HETAC Level 8 in a relevant STEM discipline with a minimum of 5 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.
- Knowledge & understanding of EN ISO 5840-3 is essential.
- Material knowledge of Nitinol and any experience with testing of Nitinol is desirable.
- Material knowledge of animal origin (bovine or porcine) is desirable.
- Basic knowledge/understanding of valve testing/kinematics.
- Basic knowledge of Finite Element Analysis.
For further information on this Senior Design assurance Engineer role in Limerick please contact Orla on 086 0449473/ email@example.com
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