Shire Jobs

JOB REQUIREMENTS: What You ll Do: As a Quality Engineer II, you will be responsible for ensuring product quality, reliability, and compliance with regulatory requirements throughout the product lifecycle. Leveraging your experience and technical expertise, you will support quality assurance activities, drive process improvements, and contribute to the development and implementation of quality management systems. Functions: Support the development and implementation of quality management systems (QMS), including policies, procedures, standards, and documentation, to ensure compliance with regulatory requirements and industry standards. Participate in product development and design control activities, including risk management, design verification/validation, and change control, to ensure product quality and regulatory compliance. Conduct root cause analysis, failure investigations, and CAPA (Corrective and Preventive Action) activities to address quality issues, non-conformances, and customer complaints. Perform quality engineering activities, including statistical analysis, process capability studies, and design of experiments (DOE), to optimize processes and improve product quality and reliability. Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and customer service, to resolve quality issues, implement corrective actions, and support continuous improvement initiatives. Lead and participate in internal and external audits, inspections, and regulatory assessments to ensure compliance with quality standards, regulations, and customer requirements. Provide technical support and guidance to manufacturing operations, suppliers, and other stakeholders to ensure adherence to quality standards and specifications. Required Qualifications: Bachelor s degree in Engineering, Science, or related field. 3-6 years of experience in quality engineering, quality assurance, or a related role, preferably in a regulated industry such as medical devices, pharmaceuticals, or aerospace. Strong knowledge of quality management principles, methodologies, and tools, including statistical process control (SPC), root cause analysis, and risk management. Experience with quality management systems (QMS) and regulatory requirements, such as ISO 13485, FDA QSR,... For full info follow application link. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, color sex, national origin, citizenship status, age, sexual orientation, gender identity, marital status, uniform service member status, genetic information, disability, or any other protected status, in accordance with all applicable federal, state, and local laws. This practice extends to all aspects of our employment practices, including but not limited to, recruiting, hiring, firing, promoting, transferring, compensation, benefits, training, leaves of absence, and other terms and conditions of employment. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/C227E4739D9441A5 This position is listed by a private employment agency. The agency is the legal employer. No fee will be charged of the job applicant.