Shire Jobs

Job Description: Coordinate quality and regulatory activities related to the Quality Management System and associated documentation. Work as part of a multidisciplinary team supporting Zoll Respicardia s commercial and continuous improvement activities. Drive and sustain improvement to the QMS to ensure ongoing regulatory and ISO 13485 compliance and that quality requirements for products, process, and/or the system will be fulfilled. Create and support documentation updates to reflect current practices, emerging needs/changes, and improvements. Coordinate various aspects of quality assurance activities such as quality review and approval of documents, training, nonconformance, lot traceability and segregation, supplier corrective action reports (SCAR), GMP compliance, GDP compliance, corrective and preventative action (CAPA), and complaint investigations to support operations activities. Coordinate documentation generation and updates in the electronic Quality Management System. Support the organization with generating documents through the system and act as system administrator for final document release and administrative updates. Coordinate user profile and training profile set up and changes for new and existing roles within the organization in the electronic Quality Management System. Work with other departments to rollout new training, upload training/certification evidence, and training due date changes. Assist in key performance indicator (KPI) metric generation and reporting for key processes within the Quality Management System critical to the business requirements. Identify improvement opportunities and lead projects to drive improvement. Conduct internal/supplier audits and support external audit preparation and execution. Assist in the organization of responses and follow-on corrective actions. Other duties as assigned. Position is fixed location based in MN office; however, telecommuting from a home office may also be permitted up to three (3) days per week. Job Requirements: Requires a Bachelor s degree (or foreign equivalent) in Engineering, Chemistry, Biology, Industrial Management or a directly related field plus two (2) years of experience as an Engineer or related occupation with experience in advancing and maintaining medical device Quality Management Systems. Experience must include: Two (2) years of experience in the following (experience may be gained concurrently): - ISO 13485 and 21 CFR820 Quality Management Systems in a quality role - Good Documentation Practices (GDP) - Supplier Corrective Action Reports and CAPAs - Investigation and root cause analysis problem solving of quality issues and complaints. 40 hours/week, 9:00am-5:00pm To apply: Send resumes to Stephanie.Davy@zoll.com. Req#[001]