Product Data Change Specialist
1921 East Alton Avenue Santa Ana, CA 92705
- This position is an important individual contributor role in the R&D or Mfg. department.
- The primary responsibility of this job is to plan and manage the configuration of documentation and parts associated with developing and manufacturing product data (DMR) throughout the product life cycle.
- This person will assist in and coordinate the creation and release of product information through the PLM system.
- He/she will drive timely release of change request according to project schedules through interaction with technical content owners and approvers from many levels of the organization as well as communicate status of documentation and parts configuration to engineers and project managers.
- Collaborate cross-functionally to create change request packages (ECRs) and assess impact of the proposed change by performing thorough impact assessments.
- Initiate and facilitate change request in compliance with applicable procedures that support compliance with regulations and standards pertaining to EW quality system change management.
- Assign part and processes numbers and assist internal customers in document formats, style, etc.
- Responsible for data entry integrity when transferring changes to product data in multiple systems.
- Responsible for ensuring that the best practices of Part/Document Change Management are followed.
- Monitor parts and documents changes management process effectiveness and contribute to problem solving/continual improvement discussions with regard to change control process, including the impact of changes and takes the initiative to recommend process improvements.
- Participate in department meetings and performs other tasks and related duties as assigned.
- Proficient and in PLM and ERP systems
- Participates in document control systems (e.g. PLM, JDE), procedures and process training
- Participates in continuous process improvements focused on systems, procedures and reporting
- Ensuring compliance with department and company procedures
- Technical and professional competencies for this position are as follows
- Requires a minimum of 3 years of experience in the Medical device or Pharma industry
- Proficient in PLM and ERP systems
- Strong technical writing skills
- Strong problem solving capabilities and project management skills
- Strong communication skills both verbal and written
- Knowledge and experience in Quality systems, solutions and processes is required
- Ability to read design and manufacturing drawings and documents.
- Skilled in tasks associated with document handling, archiving and change management.
- Associates degree is required