What are the responsibilities and job description for the Quality Specialist position at Burton Medical LLC.?
Job Description
Job Description
Position Description / Responsibilities :
- Support migration of documents into an eQMS and ensure appropriate testing and validation are done
- Perform roles of Document and Training Admin within the eQMS
- Ensure adherence to the adoption plan for timely roll-out and execution of each eQMS phase
- Align with the training team for both self-paced and instructor led training in understanding the system and operational eQMS methods
- Perform process mapping of existing documentation in alignment with the eQMS environment, working with the different SMEs at Burton for clarifications
- Update project manager in biweekly calls and manage scheduling of consultant sessions
- Train employees on use of the system and monitor results
- Assist in API integration with ERP system Netsuite
- Solicit feedback upon execution of each module and work with eQMS teams for necessary fixes and updates
- Support with document change requests through the DCR / ECO process
- Other projects, as assigned by the Head of Quality and Regulatory Affairs
Requirements :
- High School Diploma, Associates degree or Equivalent. B.S. Degree in Science or Engineering is a plus
- 2 years of experience, preferably in a manufacturing / ISO 13485 certified setting
- Excellent written and oral English skills, Spanish language is a plus
- Good documentation skills, attention to details, tracking tasks and paperwork filing
- Good computer skills with Word, Excel, MS Outlook; ERP systems and Adobe preferred; Experience with eQMS is a plus
- Basic knowledge of ISO 13485 and FDA regulations
- Demonstrated experience working with cross-functional teams
- Ability to initiate and drive continuous process improvements
- Understanding drawings, using measuring tools for product inspection and calibration
- Willingness and ability to work evenings and weekends as needed
- Limited travel to vendors
Preferences :
- Experience with onboarding eQMS, ERP or training systems, preferably for Class I medical devices
- Experience with working in an ISO certified setting
- Experience with working in projects and teams
Company Description
Burton is a medical device manufacturer engaged in the business of designing, manufacturing, and distributing high-quality examination, and surgery lighting equipment.
Since its inception in 1928, Burton has been known for superior quality, exceptional value, and long-lasting solutions to complex lighting issues facing physicians, surgeons, and veterinarians throughout the world.
Company Description
Burton is a medical device manufacturer engaged in the business of designing, manufacturing, and distributing high-quality examination, and surgery lighting equipment.
Since its inception in 1928, Burton has been known for superior quality, exceptional value, and long-lasting solutions to complex lighting issues facing physicians, surgeons, and veterinarians throughout the world.