Project Management Process Specialist

2 weeks ago


Goleta, California, United States KARL STORZ ENDOSCOPY Full time
Job Title: Project Management Process Specialist

At KARL STORZ ENDOSCOPY, we are seeking a highly skilled Project Management Process Specialist to join our team. As a key member of our project management team, you will be responsible for ensuring the successful delivery of projects across various product development initiatives.

Key Responsibilities:
  • Assist in the creation, release, storage, and maintenance of project documentation related to Design History Files, Technical Documentation, and other Regulatory and project requirements.
  • Work with Project Managers and Engineers to process documentation in the Engineering Change Management System, especially during new product development and product improvements.
  • Responsible for meeting with Project Managers regarding fulfillment of their Engineering Design Control requirements for their projects.
  • Schedule stakeholder meetings, as required, and attend meetings to document important actions and decisions.
  • Prepare necessary presentation materials for meetings.
  • Researches and gathers data, as needed, to conduct preliminary analysis. Recommends content and format to display findings most effectively.
  • Support internal and external audits.
  • Monitor GPDP documentation to ensure that project documentation complies with current standards.
  • Foster teamwork while contributing to cross-functional project teams.
  • Participate and/or assist in writing and updating procedures, protocols, and checklists.
Requirements:
  • Bachelor's degree or 5+ years of experience in a related field.
  • Minimum 5 years' experience working in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations: 21 CFR 820, ISO 13485, ISO9001.
Working Conditions:
  • Must have adequate eyesight (can be corrected) in order to work with paper documents and interface with computer.
  • Ability to lift and carry 20 pounds.
  • Stand for moderate amounts of time (2-3 hours per day).
  • Sit and input data for long periods of time (6-7 hours per day).
  • Work effectively under pressure and time constraints.
  • Communicate clearly with supervisor and co-workers.
Training Requirements:
  • Injury and Illness Prevention Program; annually - OSHA requirement.
  • Quality System training.
  • Job Specific - In house requirement.
Level of Supervision Required:
  • Minimal supervision required.
  • Individual responsible for organizing and prioritizing their time to support multiple projects.
  • Responsibilities are assigned based on general goals developed by the supervisor.

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