Quality Specialist

Mobius Mobility is seeking a dedicated and skilled Quality Specialist to join their team! This role will support Mobius Mobility’s mission by ensuring the company remains compliant with FDA and other relevant requirements, while collaborating with multiple teams across the company to keep processes running smoothly. The Quality Specialist will play a key role in quality record handling, supplier management, managing nonconforming products, document control, and training management.

• Manage suppliers and evaluate new suppliers
  
• Handle quality issues (e.g. nonconforming product) found at incoming inspection or manufacturing, including documentation and communication with suppliers
  
• Manage safety program, including training, maintaining SDS files, and conducting monthly walk-throughs
  
• Work collaboratively with personnel throughout the company to ensure quality is maintained
  
• Manage processes for approval and distribution of documents (includes internal documents such as OPs and external documents such as marketing materials)
  
• Manage training:
  

+ For new employees, ensure proper content is assigned and training is completed on schedule

+ Ensure personnel are completing required training hours and required annual trainings

+ Ensure training requirements and materials meet company needs and comply with FDA and accrediting body requirements

+ Conduct training sessions as necessary

+ Conduct training audits as necessary

• Document corrective and preventive actions (CAPAs) and/or assist in closing CAPAs
  
• Conduct file audits
  
• Perform Final Acceptance Tests and incoming inspections, as needed
  
• Adhere to all company policies and procedures
  

• Participate in the company�s Performance Improvement Program
  
• Participate in company committees when requested
  
• Participate in in-service education programs provided by the company
  
• Pursue continuing education programs appropriate to job responsibilities
  
• Perform other special projects or duties as assigned by management
  
• Report any misconduct, suspicious or unethical activities to the Compliance Officer, FDA Management Rep., Safety Officer or HIPAA Officer as appropriate
  

• Self-motivated, detail-oriented, and has a strong work ethic
  
• Strong communication skills, both written and in-person
  
• Ability to keep track of and prioritize numerous tasks
  
• Current working knowledge of MS Office
  

• Ability to move throughout the building and grounds and communicate with employees, customers and others
  
• Ability to move items weighing up to 30 lbs.
  
• Ability to travel as needed both domestically and internationally
  

Behind our brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to Mobius Mobility, where we are taking the same innovation and cutting-edge technology into the modern age.

Today, Mobius Mobility manufactures and distributes the next generation ibot® Personal Mobility Device - a breakthrough product in the field of personal mobility. With dynamic stabilization technology, the ability to climb stairs, and four distinct driving modes, the ibot® provides people with disabilities new levels of independence and access. We are committed to helping our clients reach, climb, and go - wherever and whenever they choose!

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