Job title: Quality Engineer/ Quality Manager
Location: ATU Ihub, Galway


Company:
My client are a developer of innovative medical devices which transform the mobility and quality of life of enteral feeding users. Their team understands that current feeding systems are complex, inconvenient and a burden on users’ daily lives. My client have developed the Mobility+® the first of its kind FDA cleared Elastomeric enteral feeding system. The Mobility+® is now available in the US market and has FDA Approval.



Overview:
As a Quality Engineer / Manager at this Medical Device start up, you'll play a vital role in their collaborative efforts with the Quality, Operations, and R&D teams. Your primary responsibility will revolve around overseeing all quality-related activities concerning our engagement with contract manufacturers (CM). In this role, you'll be the guardian of ensuring that the necessary regulations, standards, and requirements are seamlessly integrated into our processes. Your commitment to maintaining clear and supportive communication with contract manufacturers will be pivotal. Your contributions will extend beyond day-to-day tasks, as you'll be instrumental in translating their vision and strategic objectives into tangible, real-world results.



Requirements:

• Establish, maintain, and update the Quality Management System in compliance with FDA 21 CFR, Part 820 and ISO 13485.
• Provide quality support to operations, including leading and supporting root cause driven approaches to problem-solving efforts for quality issues.
• Manage the CAPA system and all related internal, vendor, and product-related complaints.
• Work closely with the teams in our various contract manufacturers to ensure that quality system requirements in both companies are appropriately aligned, compliant, and implemented efficiently.
• Initiate and drive continuous improvement opportunities/programs relating to manufacturing, supplier, and quality systems.
• Generate the Rockfield documentation to implement design and manufacturing changes into the contract manufacturer’s systems.
• Lead the risk management process with contract manufacturers with respect to both new manufacturing and process implementations and changes.
• Lead and coordinate/execute process and product validations.
• Manage supplier qualifications and supplier changes through the supply chain.
• Engage in supplier audits and support resolution of any non-conformances identified.
• Lead the investigation of root causes of quality issues and follow through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
• Lead any manufacturing-related activities performed in Rockfield sites as required.
• Ensure quality standards are adhered to, and all production processes are carried out according to procedures.
• Manage the document control system, including control of records as it relates to CM-related documentation and records.
• Ensure systems and documentation are compliant and retained per the Rockfield QMS.
• Perform training with Rockfield and CM personnel on manufacturing processes as required.
• Review, update, and maintain the existing electronic quality management system, processes, and procedures.
• Maintain detailed and accurate quality records, data analysis, and documentation.
• Safeguard that products meet customers’ quality and product integrity requirements and continually seek to identify and drive improvements in product and process quality.

• A Bachelor’s Degree in Engineering, Science, or equivalent/related field (Level 8).
• Minimum 5-8 years of Quality Engineering experience in the medical device industry and/or FDA regulated environment.
• Lead/Internal auditor certification an advantage.
• Start-up knowledge with contract manufacturer engagement would be valuable.
• Solid quality engineering and systems background experience.
• Demonstrated knowledge of manufacturing and systems quality experience.
• Proficient in understanding of medical device manufacturing processes desirable.
• Excellent analytical, problem-solving, and technical writing skills.
• Superb interpersonal and communication skills, with demonstrated ability to collaborate with cross-functional teams to ensure business success and ensuring compliance.