Overview
Quality Assurance Manager Jobs in Galway, County Galway, Ireland at Collins McNicholas Recruitment & HR Services Group
Title: Quality Assurance Manager
Company: Collins McNicholas Recruitment & HR Services Group
Location: Galway, County Galway, Ireland
Our client is a fast-growing medical device startup focused on developing innovative solutions that improve patient care. Their team is dedicated to advancing healthcare through cutting-edge technology, they are seeking a highly skilled and motivated Quality Manager to join their dynamic team. As a key member of the organization, you will play a pivotal role in ensuring our products meet the highest quality standards and comply with industry regulations.
Position Overview:
The Quality Manager will be responsible for establishing, implementing, and maintaining a robust quality management system (QMS) for our medical device products. This role will involve oversight of product quality, regulatory compliance, risk management, and continuous improvement initiatives. The Quality Manager will collaborate closely with cross-functional teams to ensure that quality is embedded in all stages of product development and manufacturing.
Key Responsibilities:
Develop, implement, and maintain the Quality Management System (QMS) in compliance with relevant regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, and other applicable standards).
Lead the preparation and submission of regulatory filings and audits, including the development of required documentation for FDA, CE, and other regulatory bodies.
Oversee quality control processes, including incoming material inspections, in-process controls, and final product testing to ensure compliance with specifications and standards.
Conduct internal audits and manage corrective and preventive actions (CAPAs) to address non-conformities and improve processes.
Work with the R&D, manufacturing, and supply chain teams to ensure product design, development, and manufacturing processes meet quality standards.
Provide leadership and guidance in risk management processes, including risk analysis, risk assessment, and implementation of mitigation strategies.
Lead the complaint management process, including investigation, root cause analysis, and resolution of customer complaints.
Train and mentor employees on quality systems, regulatory compliance, and best practices.
Collaborate with external partners and suppliers to ensure that materials and services meet quality requirements.
Drive continuous improvement initiatives using quality tools such as Six Sigma, Lean, FMEA, etc., to enhance product quality and operational efficiency.
Stay up-to-date with industry trends, regulatory changes, and technological advancements related to medical devices.
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
Minimum of 5 years of experience in quality management or quality assurance within the medical device industry, with at least 2 years in a managerial role.
Strong knowledge of medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820) and experience with regulatory submissions.
Proven experience in establishing and maintaining QMS and handling regulatory audits.
Strong knowledge of risk management principles and tools (e.g., FMEA, risk analysis, hazard analysis).
Experience with complaint handling and CAPA processes.
Familiarity with manufacturing processes and the ability to work cross-functionally in a fast-paced startup environment.
Excellent communication, problem-solving, and leadership skills.
Detail-oriented with strong organizational skills and the ability to manage multiple priorities.
Preferred Qualifications:
Six Sigma or Lean certification.
Experience in medical device design controls.
Knowledge of international regulatory standards (e.g., CE marking, MDSAP, etc.).
Familiarity with electronic document management systems (EDMS) and quality management software.
