Senior Quality Engineer

at  LetsGetChecked

LetsGetChecked is a global healthcare solutions company that provides the 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. LetsGetChecked’s end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives.

SENIOR QUALITY ENGINEER

We are seeking a detail-oriented Senior Quality Engineer to join our dynamic team at our Manufacturing Facility in Dublin, to ensure our products and processes comply with relevant regulations and standards, including ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, and ISO 14971. 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.

• 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.
• Stay updated on regulatory changes and industry best practices, integrating quality into all aspects of work, and offering problem-solving recommendations to the operations and engineering teams.