Our client, a medical device company in Limerick is currently looking to recruit a Senior Quality Engineer (Design Assurance) for their site.
This role will be supporting Quality Design Assurance for the Infusion Pump platforms. The Senior QE is involved in new product development and product maintenance through the application of Quality engineering skills. Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance utilizing a high level of written and oral communication skills.
Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements. Represents the Quality Function on Project Teams for both new product development and existing products.
- Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance…) as needed for the project.
- Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product lifecycle.
- Write project quality plan
- Lead risk management activities within the project.
- Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.
- Assist / conduct Failure investigations and problem-solving sessions
- Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports.
- Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
- Ensure process validation activities are completed appropriately and make the link with product design whenever needed.
- Conduct quality functional reviews and DHF compliance reviews.
- Ensure compliance across projects for design control, risk management and change control processes. Support Quality culture within R&D organization while providing training on applicable requirements / standards.
- Role assigned to MMS Infusion Platforms “Alaris+” and “GAI”
- Quality Engineer role based at Research Center Ireland, Limerick
- QE Role assignments includes R&D projects for New Product Introduction and Product maintenance (mechanical, electrical, software design….)
- QE role interacts with key functions across BD Worldwide organization (R&D, Operations, Reg Affairs, Medical Affairs) and external projects partners (key suppliers, contract labs, CMOs).
Position Specific Overview
- Reliability: Understand basic Reliability Engineering practices. Includes familiarity with: Reliability Growth Testing (RDT), Reliability Demonstration Testing (RDT), Life Test, HALT, HASS, Idealized Growth Curve, etc.
- Software: Understand the software development (SW) and testing life cycle as defined by ISO 62304.Experience supporting SW-related R&D design change efforts through development and/or testing. Understanding of SW issues tracking, automation, issues tracking, risk assessment and bug containment.
- Compliance: Ability to support R&D efforts specifically aimed at compliance with domestic or international (e.g. MDR, IEC 60601, 3rd Edition, ISO 13485) requirements. Experience supporting or navigating such projects. Interacting with governing bodies and test houses.
- Good understanding of technical aspects: injection molding, extrusion, polymer science, electrical engineering, mechanical engineering, chemical testing
The successful candidate will possess:
- Bachelor’s Degree in Engineering required, electrical or mechanical preferred
- Minimum 5-7 years of medical device quality engineering experience
- Expertise in design assurance including design controls and risk management
- Embedded software validation experience
- Capital Equipment validation
- General understanding of Statistical methods for quality assurance
- Ability to act as Change Agent and effectively manage change
- Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams
- Demonstrate strong and clear accountability for successful and timely completion of tasks
- Influence: Intuitively and quickly assess people and situations and act accordingly. Demonstrate persuasion and timing skills. Remain open to be persuaded when appropriate.
- Prefer infusion pump experience or drug delivery experience (regulated FDA industry)
For further information on this Design assurance role in Limerick please contact Orla on 086 0449473/ email@example.com
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