Our client a Galway based startup are looking to hire a Quality Manager and they expand operations and bring their products to market.
The Role:
As the Quality Manager you will get the opportunity to apply your engineering knowledge in areas such as quality systems, supplier controls, design assurance, test method development and validation, design controls, and regulatory affairs during this exciting time as they bring their products to market.
Responsibilities:
Apply quality engineering principles and expertise in various areas throughout the Quality Management System.
Lead the Management Review process including continuous monitoring and improvement to relevant KPIs and Quality Objectives.
Perform necessary internal and external reporting to regulatory bodies and management team.
Lead the development and certification to ISO 13485 and QMSR and ensure on-going maintenance and audit readiness.
Lead Design & Development activities, including design controls, verification and validation activities and ensure the DHF is adequately maintained.
Support the development and validation of test methods to access the performance and quality of medical devices.
Lead the development and validation of computer system validation / assurance programs to meet regulatory requirements.
Lead and collaborate with all relevant departments to support quality policy and quality objectives.
Lead customer feedback processes, including customer complaints and investigation and reporting.
Support Usability Engineering activities, including identification of User Needs and Voice of the Customer (VoC).
Lead risk management activities and usability engineering.
Lead document control activities through QT9, including the performance of administrative duties of QT9 (eQMS).
Demonstrate strong initiative follow-through, and effective project leadership in the execution of responsibilities, overcoming obstacles, and managing multiple priorities.
Drive CAPA and NC management and investigation to effective and timely resolution.
Support the Internal and External Auditing Program and resolution of any actions arising.
Support the identification updates to relevant Standards and Guidance, including appropriate GAP assessments to support product development certification.
Lead the Supplier Quality Management activities, including maintenance of supplier selection and evaluation, maintenance of Approved Vendor Listing and associated documentation.
Perform an integral role in Quality Operations ensuring the Device Master Record (DMR) / Device History Records (DHR) are adequately maintained.
Identify requirements for and perform lot release duties as required.
Support the identification of resourcing needs, training and competency within the quality team and attend to performance reviews as appropriate.
Other duties as required to support business goals and key performance indicators.
Requirements:
Minimum bachelor’s degree in science, engineering, or related field or equivalent.
Minimum of five (5) years in a medical device organisation.
Experience with medical device regulations including GMP (Good Manufacturing Practices), FDA QMSR (Quality Systems Regulations), and ISO 13485 quality requirements, is required.
Experience working in both an FDA and European regulatory environment is preferred.
Strong initiative and follow through in executing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
Excellent problem-solving, decision-making, and root cause analysis skills are desired (DMAIC).
Knowledge and demonstrated practice of risk management methodologies as per ISO 14971.
Experience in supplier quality, quality assurance, quality systems, design assurance or regulatory affairs is an advantage, though not required.
Experience in Ethylene Oxide sterilization, Gamma Sterilization, Biocompatibility, Labelling and Packaging, Storage and Transportation requirements or testing is an advantage, though not required.
Prior quality planning, internal and external audits or inspections experience is an advantage.
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717