At LetsGetChecked, we empower people to take control of their health and well-being.
The company provides tools and solutions for managing health from home through health testing, virtual care, genetic sequencing, and medication delivery. Our end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment.
Job Overview
We seek a highly skilled Senior Quality Engineer to join our team at our Manufacturing Facility in Dublin. The successful candidate will be responsible for ensuring that products and processes meet relevant regulations and standards.
Responsibilities
* Evaluate current products and processes to ensure compliance with applicable regulations and standards.
* Review and approve change controls guiding the team through the change process to maintain compliance.
* Review and approve validation deliverables for manufacturing equipment and processes and identify effective process controls.
* Participate in internal and external audits taking on various roles within the audit team and leading audit preparation resolution of audit findings by liaising with process owners and managers.
* Lead risk management activities maintain risk management documentation and assess risk mitigation techniques identify potential failure modes defect frequency severity risk process controls etc.
* Collaborate with cross-functional teams to implement changes and automated production systems for efficient quality issue resolution.
* Provide mentorship to Quality team personnel on meeting daily work priorities and team goals with direction from management and technical guidance in identifying and resolving quality issues using six sigma lean and related tools/techniques.
* Responsible for analyzing and summarizing potential issues by assessing impact on customer safety and product quality and to make decisions related to the disposition of non-conforming product.
* Contribute towards investigation of CAPAs and non-conformances and review applicable records and documentation for completion at critical phases.
Requirements
* Minimum 5 years of relevant experience in an engineering or quality role or an advanced degree preferably in Quality Biomedical Engineering with a minimum 3 years of experience in a quality department.
* Good working knowledge of ISO 13485 21 CFR Part 820 MDR 2017/745 IVDR 2017/746 ISO 14971.
* Proficient in using SAP S/4 HANA particularly the Quality Management QM module.
* Experience with internal and external audits and a professional certification in Quality Auditing i.e. Certified Lead Auditor or Internal Auditor is required.
* Experience in reviewing technical documentation assessing impact of proposed changes on the QMS by working constructively with stakeholders across all business areas of the organization.
* Experience with new product introduction Class II medical devices Class A IVDs and have significant expertise in validation engineering risk analysis and documenting risk management reports.
* Knowledge of root cause analysis continuous improvement activities and execution and verification of effectiveness techniques.
* Hands-on using Statistics Lean and Six Sigma methodologies is required Minitab experience is an advantage.
* Ability to work independently in a fast-paced medical device manufacturing environment and able to multitask and prioritize tasks to meet high expectations and tight deadlines.
* Project and people management skills are needed along with the ability to mentor the team and foster a positive work environment.
* Excellent analytical troubleshooting process improvement critical thinking and decision-making skills.
* Strong technical writing and exceptional verbal communication skills.
The ideal candidate will possess excellent analytical and problem-solving skills, with the ability to work effectively in a fast-paced environment. They will also have strong technical writing and verbal communication skills, with the ability to provide clear and concise feedback to colleagues and management.
What We Offer
As a Senior Quality Engineer at LetsGetChecked, you will have the opportunity to work with a dynamic team and contribute to the development of innovative healthcare solutions. You will also have access to ongoing training and professional development opportunities to help you grow in your career.