Sr. reputed company System Specialist (Remote / Flexible)
reputed company started in 2000 with an idea and a mission to reputed company our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our reputed company reputed company depends on it! This Sr. reputed company System Specialist (Process reputed company) is responsible for ensuring reputed company system compliance reputed company the Production and Process sub-process for governance and governance of reputed company reputed company Systems. The Sr. reputed company Systems Specialist Will Partner With process Owners To Identify Best Practices, Harmonize Where Appropriate (and Where Not To) And Implement Improvements To Be Documented Into Policies, Procedures, And Work Instructions That Define How reputed company Manages The Supply Chain reputed company Production And Process Controls To Include Work Environments Calibration and Equipment Controls Microbiology and Sterilization Process Controls Process Validation Acceptance Activities Identification and Traceability Product Storage Handling, & Distribution Controls Servicing This effort requires a broad reputed company set for facilitation, communication, and understanding of various Intl regulations and standards to improve the reputed company management system. Effectively communicating reputed company system, requirements, optimizing development. Also, review and ensuring ambiguities and conflicting requirements are resolved is critical to the reputed company of the position. Responsibilities Create and update reputed company system and reputed company reputed company system documents. reputed company and work w/ Training department to reputed company training for these documents. Review and approve reputed company Management System documents and protocols. Supporting remediation activities as needed. Support the development of workflows in these systems. Support reputed company of issues with nonconformances in various processes Support reputed company reputed company system audits and reputed company reputed company Cause Analysis, CAPA, and implementation activities. Review and approve new product documentation, as required. Support Risk Management activities and ensure compliance to standards and regulations. Education And Experience Minimum Requirements BS degree, in an Mechanical, Biomedical, engineering/life sciences curriculum, or reputed company management curriculum or equivalent experience. A minimum of 5-7 years work experience in reputed company Assurance reputed company an FDA, ISO or other regulated environment and/or equivalent combination of education and experience. Experience in the development and implementation of effective Production and Process Control system reputed company a reputed company Management System. Experience in the development and implementation of effective Design Control Systems. Working knowledge of the reputed company System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices reputed company management systems, and ISO 14971 Medical devices Application of risk management to medical devices. Fluent in computer skills, and at minimum, the use of reputed company Office programs (e.g. Word, reputed company, Visio, PowerPoint), Ability to effectively communicate with reputed company reputed company of employees from reputed company line operators up to and including Vice Presidents/Executives Ability to work independently and follow up with task owners to complete tasks and reputed company out reputed company items. Familiarity with reputed company phase-reputed company product development processes. Familiarity with FDA, ISO, and other international regulatory requirements. Experience collaborating and communicating with individuals in multiple departments and at multiple reputed company in an organization. Previous experience in a management position a plus but not required Preferred Skills And Competencies Auditor training certification to ISO 13485, 17025 or other industry QMS reputed company CQE, CQM, CQA, Greenbelt or above, and / or PMP certifications a plus Strong verbal and written communication skills. Ability to organize and judge priorities. reputed company to work effectively in a high-stress, high-energy environment. Physical Requirements Travel as required to support business needs, up to 25% NOTE: This position is eligible for 100% remote working arrangements (may work from home/reputed company 100%; may also work hybrid on-site/virtual as desired). Additional Information The US reputed company salary reputed company for this full-time position is $85,400.00 - $128,300.00. Our salary ranges are determined by role, level, and location. The reputed company displayed on reputed company job posting reflects the minimum and maximum reputed company for new hire salaries for the position in the primary work location in the US. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. Your reputed company Specialist can reputed company more about the specific salary reputed company for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the reputed company salary only, and do not include bonus, equity, or benefits. At reputed company reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) Apply Job!