01 Aug
Labeling Project Lead
California, Milpitas , 95035 Milpitas USA

Vacancy expired!

Job Description This position is responsible for directing the activities related to the execution of labeling, Manual and/or packaging projects. The position will be required to interface with all project stakeholders, including stakeholders at multiple sites (e.g., regulatory affairs, quality assurance, labeling, manufacturing, sourcing, etc.), to develop the appropriate timelines and ensure the assembled teams can successfully execute the assigned projects. ESSENTIAL DUTIES AND RESPONSIBILITIES Act as the team leader for Labeling, Manual and/or Packaging Projects, Starting with project charter through label development and label implementation at the manufacturing facility. Facilitate the development of the labeling requirements for new products or revisions to current products. Develop, assist in developing, and/or execute protocols and evaluations of products affected by design changes. Prepare and manage labeling project schedules and communicate labeling schedules to the project team Responsible for Labeling / Manual reviews as needed. Responsible for communication of team objectives, charter, milestones and progress Owner of project status updates for Projects, Preparation of reports and presentations. Partner in continuous improvement of Packaging and Labeling Processes and Procedures. Work with all stakeholders to build consensus on areas for improvement. Manage the scoping and execution of the electronic management of workflow. Ensure products are packaged and labeled in accordance with Corporate and Division product development policies. Knowledge and understanding of FDA and ISO medical device development regulations; especially as they pertain to design control and product development. Knowledge of standard operating procedures, as they relate to Product Labeling and Sustaining Engineering. Strong analytical thinking, questioning & problem-solving skills. Education and/or Experience: Minimum undergraduate degree (BS) in a technical area (Mechanical Engineering) and a minimum of three-years' experience in medical device or pharmaceutical industry. Change Orders Experience with Agile PLM or any PLM is highly desired. Prior knowledge of medical device packaging, labeling, labeling management software, UDI, GS1 barcode and MDR a plus.Mukesh PandeyP: 732-385-3423: E: mukesh.p@e-solutionsinc.comDisclaimer: E-Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability.

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