Senior Quality Engineer

Aran Biomedical

Galway

ROLE DESCRIPTION. We have an exciting opportunity to join our team in Galway, Ireland. The Senior Quality Engineer works as part of a team to maintain high quality/performance standards across the Company. Reporting directly to the Senior Quality/Regulatory Manager the position is challenging and requires a highly motivated candidate who has the ability to work autonomously. COMPANY INFORMATION. Headquartered in Spiddal, Co. Galway (15 minutes West of Galway City) Aran Biomedical is a leading innovator in the research, design, development and manufacture of biomaterial product solutions for medical implants. The Company has experienced strong growth over the last 15 years and has ambitious growth plans over the next couple of years. At Aran Biomedical, our people are the cornerstone of our business. Our teams work hard yet are always open to having fun. Aran prides itself on creating both a professional and social culture internally & externally. The company prioritises relationship building amongst our teams. KEY RESPONSIBILITIES. Act as the QA representative on Design Services Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation. Develop and maintain documentation in compliance with FDA, ISO, MDD requirements. Initiate / Approve Validation protocols and reports (IQ, OQ, PQ. Initiate / Approve Engineering Change notices. Process Customer Complaints and manage customer replies. Actively participate in the Documentation control process. Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations. Participate / Lead Risk Analysis initiatives e.g. FMEA. Initiate / Approve Reworks. Initiate / Support implementation of effective Corrective / Preventive Actions. Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc. Represent QA as part of the Material Review Board. Perform Internal and Supplier Audits. Support Notified Body / Regulatory Agency / Customer Audits. Review / Approve / Release final product documentation. Support the Environmental monitoring process. Support activities associated with Sterilization. Act as the QA representative for Supplier Quality management activities. Collate and trend Key performance indicator data. Actively participate in Management Review & Compliance meetings. Act as delegate for Quality Manager when required. KNOWLEDGE, EXPERIENCE & SKILLS. Hold a third level Manufacturing Engineering, Quality Engineering, Life Science or related field Degree. Minimum of 5 years industrial experience in the Medical Device Industry. Experience of using lean manufacturing tools and techniques is an advantage. Quality Certification or Lead Auditor training is an advantage. KEY COMPETENCIES. Good communication skills. Detail orientated- ability to keep detailed documentation. The energy, enthusiasm and drive to make it happen. A team player who has the ability to motivate others, making it fun while getting the job done. Enjoys working in a fast-paced, innovative environment. Adaptable and flexible in approach to work. This job originally appeared on RecruitIreland.com.

2066 days ago