Fresenius Medical Care North America Sr. Quality Systems Specialist - NxStage in Lawrence, Massachusetts
Job ID 210002PX
Available Openings 1
The incumbent will support the Document Control Process improvements, responsible for maintaining and updating Document Control Procedures. This position will assist with processing and implementing change orders.
Leads and/or participate in Document Control System process improvements
Responsible for Agile Administration, work with IT or outside vendor to resolve or enhance Agile software.
Develop / enhance department procedures and processes.
Work with cross functional departments to maintain and improve Document Control tools.
Guide change initiators and partner with cross-functional teams in the development of change orders
Develops and delivers training regarding change control processes to promote high quality documentation, efficient processes, and compliance with quality system requirements.
Assist with processing and implementing change orders in the electronic document control system (i.e. Agile).
Evaluate quality data and prepare periodic reports to monitor trends
Prepares and provides applicable metrics data to management.
Participates in and responds to internal and external audits
Perform other duties as assigned by manager.
PHYSICAL DEMANDS AND WORKING CONDITIONS :
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The individual will, for the most part, be seated and work at a computer and utilize telephone equipment.
Bachelor’s Degree required or equilivant work experience
EXPERIENCE AND REQUIRED SKILLS:
5+ years related QA (experience in a med device company preferred)
Functional knowledge of FDA Quality System Regulation 21 CFR Part 820.
Good organizational, attention to detail and follow-through skills
Excellent verbal, written, organizational and time management skills.
Ability to interface with multiple groups in the organization.
Strong computer skills, including working knowledge of MS Office and e-mail.
Strong problem solving and customer service skills
Thorough understanding of change control and documentation regulations (medical/safety/regulatory/corporate).
Experience in cGMP/GDP/GCP environments and FDA regulated industries strongly preferred.
experience with electronic document control system.
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
Fresenius Medical Care North America
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