Posted in: Other in Limerick | Posted: |
Senior Quality Engineer - Design Assurance - Medical Device
The Design assurance 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.
As a Senior Quality Engineer you will:
- Be 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 .
- Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product life cycle.
- Write project quality plans
- 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.
The successful candidate will have a minimum level 8 degree in related discipline and have proven expertise in design assurance including design controls and risk management (ISO 14971), reviewing and approving test protocols, SPC, experience working with Design History Files (ISO 13485) and have experience working in the medical device sector.
Additional experience with Software Quality (ISO 62304), Capital equipment validation and reliability testing is an advantage.