Shire Jobs

JOB REQUIREMENTS: Job Description: The Senior Supplier Quality Engineer will develop, establish, and maintain supplier quality management practices that meet Agiliti, customer, and regulatory requirements. PRIMARY DUTIES AND RESPONSIBILITIES Senior Supplier Quality Engineer Participate in all applicable Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), Complaint/Incident investigations and Corrective and Preventive Actions (CAPAs) Participates with quality members in the product development processes and documentation including, but not limited to supplier new product qualification and supplier development process. Execute tasks associated with continuous improvement activities. Provides data for predefined metrics for supplier monitoring. Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Ensures compliance with internal and external regulatory agencies. Facilitates accurate and timely completion of customer and quality records. Ensures that supplier corrective measures meet acceptable standards. Applies statistical methodologies for assessment and to resolve potential product and quality system issues. Leads small projects within team or across one to two departments Work independently; minimal daily direction required to successfully develop deliverables Leads qualification of supplier selection and approval process Guides, supervises, and or/coaches others on the quality team. May supervise a team. Creates and maintains project schedules and delivery milestones for completion. Up to 50% travel required, with opportunity to plan travel schedule REQUIRED EXPERIENCE Senior Supplier Quality Engineer: Bachelor\'s degree in Engineering or life sciences required. Minimum 5 - 8 years Quality Engineering experience OR advanced degree with 3 - 5 years of applicable experience. Experience with ISO 13485, 21 CFR Part 820, and Medical Device Good Documentation Practices. Experience guiding and coaching others. 3+ years of experience leading supplier quality management and new product development projects, Experience improving and maintaining an effective Quality Management System. REQUIRED SKILLS & ABILITIES Proficient computer skills in MS Office Suite Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485 Strong analytical skills including application of statistical techniques Strict attention to detail Strong technical writing skills and effective communication skills Strong presentation, facilitation, and project management skills This job description in no way states or implies that these are the... For full info follow application link. We are proud to be an EEO/AA Employer/Vet/Disabled. We maintain a drug-free workplace and perform pre-employment background and drug testing. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/5D22222347344FF4