12-month initial contract
Hybrid
Responsible for the successful completion of assigned projects, including scope definition, design specification, project plan development, implementation, and validation. The individual will be required to interface with other functional areas within the company and with resources outside of the company (vendors, consultants, etc.) to complete the assigned projects within the deadline.
Works closely with Project Management staff to facilitate product development and assist in preparation and review of product design deliverables for the development and commercialization of instrumentation systems.
This position requires specialized knowledge and skills in the functional areas, particularly interfacing with project management, design and documentation control and the scientific staff. This position also networks with other functional areas within the company as required to expedite the product development and design change process. Monitors work to ensure quality, and continuously promote Quality First Time.
Responsibilities:
• Coordinates tasks and deliverables for assigned projects. Responsibilities include scope definition, project plan development and maintenance, and implementation.
• Interfaces with internal and external resources to ensure timely completion of tasks and deliverables.
• Coordinates and manages timelines and resources to ensure project deliverables are completed on time.
• Ensures that each team member understands their responsibilities and accountabilities.
• Facilitates product development and design change process. Assist in preparation and proactive communication of product design deliverables.
• Creates, updates and/or reviews Operating Procedures, Device History File, Validation Protocols, DCOs, and other technical documentation to ensure consistency, quality, standardization and completeness. Continuously promotes Quality First Time
• Accountable for identifying, planning, and tracking documentation deliverables according to the Product Development Process (PDP) and Quality System processes. Participates in project planning and advises project leadership on best practices, tailoring of deliverables, timelines, and risks for the given project type.
• Manages change workflows via the Electronic Document Management System (EDMS).
• Makes appropriate recommendations to management.
• Schedules and facilitates meetings, takes notes and tracks action items.
• Other duties as assigned by management.
Qualifications:
Bachelor's Degree in business administration, life science, engineering
or equivalent combination of education and experience (3 years of combination of education and/or experience).-Preferred
Experience:
3 years of relevant experience in a regulated and/or product
development industry.- Required
3 years of prior experience coordinating or managing projects
and/or business initiatives.-Required
3 years of Quality Assurance experience.-Preferred
Knowledge, Skills and Abilities:
• Strong written and verbal communication skills.
• Proficiency with word processing, spreadsheet, database and email software
• Ability to manage by and meet deadlines.
• Excellent time management, planning, organization and problem solving skills.
• Must be people-oriented and a team player.
• Ability to multi-task and prioritize.
Travel Requirements:
As needed -Based on business needs
