GHR Consulting
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Quality Manager
Location:
Galway, Co. Galway
Description:
The Company:Our client is an acclaimed medical device company recognised for its innovation in developing orthopaedic technologies to address unmet clinical needs within the orthopaedic extremities field, ultimately transforming the lives of millions of individuals globally. Due to ongoing expansion, they are looking to hire a Qulaity Manager to join their team.The Role:As the Quality Manager, you will play a pivotal role in establishing and maintaining a robust Quality Management System (QMS) in compliance with EN ISO13485:2016, EU MDR and 21 CFR Part 820 regulations. You will oversee various quality assurance and regulatory activities, ensuring adherence to organisational and external requirements throughout the product lifecycle.Responsibilities: Lead the development and maintenance of the Quality Management System (QMS) according to EN ISO13485:2016, EU MDR and 21 CFR Part 820.Manage non-conformance and Corrective and Preventive Action (CAPA) processes, including containment, root cause analysis, and product disposition.Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.Management of Design History File (DHF) and Device Master Record (DMR) in accordance with US and European regulatory requirements.Provide design assurance oversight and active participant in all stages of design development, testing and design control activities, ensuring quality assurance considerations and requirements met.Provide support to R&D, clinical, and manufacturing development activities.Ensure compliance with all organisational and external regulatory requirements.Plan, execute, report, and follow-up on subcontractor and supplier audits.Document and implement design and process validations in accordance with industry standards.Collaborate with other departments to streamline product approval and manufacturing processes.Facilitate supplier correspondence for key projects and drive quality improvements.Provide QA support in the review and approval of plant related validation protocols, reports, and change requestsOversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicatorsDevelop and implement continuous improvement programs in collaboration with Operations and R&D functions.Act as the lead complaint coordinator and oversee complaint handling processes.Provide technical support to project teams during process development, transfer, validations, and product commercialisation. Requirements: Bachelor's degree in an engineering discipline.Minimum of 5-7 years of experience in quality management within the medical device industry.Ability to lead the quality team and drive a culture of quality within the organisationStrong knowledge of EN ISO13485:2016 and 21 CFR Part 820 regulations.Proven track record in managing non-conformances, CAPA, and root cause analysis.Experience in supplier management, auditing, and quality systems implementation.Excellent communication and interpersonal skills; ability to collaborate effectively across departments.Strong problem-solving skills with a proactive approach to quality improvement.Detail-oriented with a focus on documentation and compliance.Ability to thrive in a fast-paced, dynamic startup environment. Desirable: Experience with the preparation of FDA, CE, Ethical Committee, and Competent Authority file submissions.Experience with event reporting during clinical trials.Entrepreneurial spirit with a positive can do attitude Benefits: Competitive salary and benefits packageFlexible and Hybrid working solutionsNew office fit out with modern and well-appointed officesOpportunity to work in a well-funded scaling Start upOpportunity to work with a passionate team in a cutting-edge field
Company:
GHR Consulting
Posted:
April 25 on HireLocker
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More About this Listing: Quality Manager
Quality Manager is a Quality Assurance Quality Manager Job at GHR Consulting located in Galway G. Find other listings like Quality Manager by searching Oodle for Quality Assurance Quality Manager Jobs.
Quality Manager is a Quality Assurance Quality Manager Job at GHR Consulting located in Galway G. Find other listings like Quality Manager by searching Oodle for Quality Assurance Quality Manager Jobs.