As a Project Management Process Specialist at KARL STORZ , you will be involved in all new and change product development projects and provide fundamental support. The successful candidate must be able to balance multiple projects at one time while maintaining the same level of quality across each program.
The Project Management Process Specialist works with Project and Program Managers to create, release, and store documentation related to Design History Files (DHF), Technical Documentation, and other Regulatory and project requirements. You will monitor submitted documentation to ensure that it complies with current process standards and provide local support and guidance for Global Product Development Processes (GPDP). The Project Manager Process Specialist will also support project related internal and external audits.
ESSENTIAL FUNCTIONS: List the essential duties and responsibilities of the position, in order of importance and/or amount of time spent.
- 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.
- Regular attendance is an essential job function.
- Travel: up to 10% travel during the year.
ADDITIONAL RESPONSIBILITES:
The Project Management Process Specialist will spend part of their time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of Karl Storz’s products and services.
Responsible for creating and maintaining work instructions for job specific duties.
Performs other related duties as assigned by supervisor
KNOWLEDGE, SKILLS, ABILITIES:
- Demonstrated experience understanding and following documented protocols and procedures.
- Exceptional verbal, written and presentation skills
- Proficiency in Microsoft Office 365
- Ability to work on multiple projects and priorities simultaneously
- High level of interpersonal skills to handle sensitive and confidential information and documents
- Drive and passion to learn new applications in project support and process management
- A proven track-record of problem resolution and the ability to make sound decisions in a fast-paced environment
- Excellent teamwork capabilities
- Experience in documentation archival systems and/or SAP
- Strong capabilities within MS Word for formatting and developing forms and templates
- Strong capabilities within MS Excel in creating formulas and pivot tables
- Must be proficient in simple data analysis techniques, primarily using MS Excel
EDUCATION AND EXPERIENCE:
- Bachelor’s degree or 5+ years of experience in 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.
PHYSICAL & MENTAL REQUIREMENTS:
- 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.
INTERFACE.
- Project Managers- to create, release, store, and maintain project documentation related to Design History Files, Technical Documentation, and other Regulatory and project requirements.
- Product Development Project Team Members, Manufacturing, QSSC, Compliance- same as above
- Internal and External Auditors – front and/or backroom coordinator or interface for Product Development documentation related questions.
- Document Control and EC Change Board members- Coordination of product release to EC system.
- It is each employee’s obligation to consistently treat visitors, external customers and all co-workers with courtesy and respect
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