Senior QA Operations Engineer (6 Month C
Provide Quality Assurance support to the stent Supplier, to ensure that manufacturing is performed in a manner that assures product quality and meets regulatory requirements. Travelling between Galway officer and Hamburg (Stent Supplier. Responsibilities: Manage the relationship with the stent manufacturer to ensure that our product quality requirements are achieved. Closely oversee the stent supplier QMS activities, as they relate to our product, to ensure that our related compliance activities are performed in line with applicable regulatory requirements. Lead the activities associated with preparing the stent supplier to achieve a successful FDA inspection. Providing status updates to our Management. Review supplier changes ensuring product impact is assessed. Support Risk Management activities as required. Review and contribute to process validation activities of the stent Supplier. Drive SCAR, CAPA and NCR activities to closure with the stent Supplier. Drive stent supplier audit NC’s, ensuring they are closed out in a thorough and timely manner. Develop and mentor other team members. Support Activities. Support the Finished Device Manufacturing Subcontractor to ensure that our product quality requirements are achieved. Support the Complaint Coordinator in evaluation/investigation of product complaints. Support R&D and Design Assurance in development activities linked to the principal responsibilities above. Auditing of subcontractors and suppliers. Perform lot review and lot release activities. Education: Educated to a Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline. Training. No specific training requirements. However, Training / Qualifications in CAPA, Auditing, Risk Management and Quality System experience is highly desirable. Experience. A minimum of 7 years’ manufacturing quality experience in a medical device manufacturing environment, is required. Excellent attention to detail, communication skills, problem solving skills, people and team working skills is required. Capable of working under minimal supervision. FDA inspection experience is desirable. Experience of managing suppliers is desirable. Experience in process validation and risk management activities is required. Auditing experience, both internally and of suppliers is desirable. Regulatory / Quality Requirements: ISO 13485. 21 CFR 820. ISO 14155. 21 CFR Parts 50, 54, 56, 812. MDD. ICH GCP. Quality management system experience. CAPA. Auditing. Risk Management (including FMECA) (ISO 14971. Relationships – Internal: Interaction with QA, R&D and Operations at all organizational levels daily. Routine contact with all functions and levels of personnel within our Company. Relationships – External: The Senior Quality Engineer will be working with the stent supplier daily. Therefore, it will involve a minimum of 50% time working at the stent supplier facility. The Senior Quality Engineer will need to be assertive in ensuring that our product quality and compliance needs are satisfied, while simultaneously fostering good working relationships and a spirit of collaboration. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: email@example.com. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. This job originally appeared on RecruitIreland.com.
188 days ago