Healthcare Professional Opportunity
About the Role
We are seeking a detail-oriented Senior Quality Engineer to join our team at our manufacturing facility in Dublin, to ensure our products and processes comply with relevant regulations and standards. This role involves reviewing and approving change controls, validating manufacturing equipment and processes, participating in audits, leading risk management activities, and providing mentorship to the quality team.
Key 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.
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 is required.
About Us
We are a global healthcare solutions company that provides tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. Our end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. We empower people to take control of their health and live longer, happier lives.
We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey.
What We Offer
* Health insurance and an Employee Assistance Programme.
* Annual Compensation Reviews.
* Flexible Annual Leave.
* Free monthly LetsGetChecked tests.
* Referral bonus programme.
* Internal Opportunities and Careers Clinics.
* Bike to work scheme - and secure bike storage onsite.
* Maternity, Paternity, Parental and Wedding leave.