Job Description
Our client based in Sligo are looking to hire a Quality Manger on an initial 2 year contract with a view to permanency after the two years. The Role: The Quality Assurance Manager operates within the Quality Assurance organization, focusing on feedback and service activities to support and guide the business in fulfilling their regulatory obligations related to managing their product portfolio. Responsibilities: Lead a small team to achieve the following: Support the site by providing quality assurance and technical support to stakeholders to meet corporate and regulatory timelines. Identify and address quality issues related to product design, manufacturing, and safety quality programs. Assist the complaints team in ensuring all actions are investigated in a timely manner and comply with procedures to meet the requirements of the device complaint and CAPA management system. Proactively investigate and address customer feedback and/or repair data to identify potential issues and minimize market impact. Coordinate and ensure timely review and approval of quality agreements. Ensure appropriate training is identified for the service centre. Manage the CAPA process for the device. Coordinate the service Centre processes and key performance indicators. Coordinate the audit program schedule for the service centres. Ensure all documentation complies with device requirements, applicable regulations (MDR/MDD), and ISO standards. EHS Responsibilities: Ensure compliance with Environmental Health & Safety standards, adhering to all EHS regulations and procedures. Demonstrate accountability for EHS performance through active participation and support of the EHS program. Report any work-related injuries or illnesses to employee health and assist in investigations. Participate in EHS programs and attend assigned EHS training sessions. Strive to meet EHS goals. Requirements: Third-level qualification in a related field, with a minimum of 5 years of experience in the medical device industry, including at least 3 years in progressively responsible roles and experience leading a project. Auditor or lead auditor qualifications are an advantage. Strong interpersonal skills, capable of working independently or in teams with minimal supervision. Proven people management skills through managing staff, mentoring new hires, or leading training programs. Proactive attitude, excellent organizational skills, and the ability to manage multiple projects while meeting deadlines. Strong analytical, critical thinking, and problem-solving skills, including the ability to perform root cause analyses and quality data evaluations. Working knowledge of recognized Quality Management Systems and global medical device regulations (e.g., ISO9001, ISO13485, ISO14971, cGMP, CE). Proficiency in MS Office applications (Word, Excel, PowerPoint) and familiarity with Power BI is a plus. Experience working with electronic quality management systems. Experience with post-market surveillance is advantageous. Willingness to travel internationally (approximately 5-10% annually). For more information and a confidential discussion on the role please contactMichelle Mc Inerney. Skills: Quality Operations Manager