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Sr. Manager of Quality and Regulatory - Extron 

Category Management  

The Sr. Manager of Quality and Regulatory will provide quality management and regulatory affairs leadership across the business. The will provide strategic direction, training, and support across the organization.

Responsibilities and Duties:

  • Develop, administer, and maintain quality assurance procedures and activities.
  • Responsible for ensuring the business activities are conducted in compliance with the regulations and standards applicable to our business and the needs of our customers.
  • Responsible for planning and hosting external quality audits/inspections of our facilities.
  • Ensure all business processes are fully supported by appropriate documentation.
  • Perform batch record reviews, in-process final release audits and dispositions of final product to assure procedural adherence of the organization
  • Assist in the preparation for and conducting of internal and external audits.
  • Develop, establish, implement and maintain the processes needed for the quality system to function effectively.
  • Review all change orders, deviations, incident reports, NCR's and CAPA's.
  • Coordinate with other heads of departments, integrating objectives and ideas for organizational growth of the business.
  • Perform day-to-day administrative tasks, such as processing information files and other paperwork
  • Manage and coordinate all services related to Return Material Authorization (RMA's), on-site technical support activities, client technical questions, etc.
  • Supervise quality assurance specialist and quality coordinator.
Position Requirements
  • Strong analytical, organizational, and communication skills (verbal and written)
  • Excellent managerial and supervisory skills
  • Excellent analytical and problem-solving skills
  • Self-motivated and “Can Do” attitude, willing to be flexible, with the ability to adapt to change.
  • Ability to work under pressure and tight schedules
  • Decision making skills: He/she should have the ability to analyze information and evaluate results in order to make the best decision in solving problems
  • Planning skills: – He/she should have the ability to develop specific plans and goals to help in accomplishing tasks efficiently
  • Motivating skills: He/she should be able to encourage and build team spirit among staff, bringing about mutual respect and cooperation
  • Proficient in Microsoft Office Suite and other software systems.
  • He/she must have pleasant personality and display managerial and leadership abilities
  • A proven track record in identifying, documenting, and solving problems
  • Able to provide customer-facing support when they call in with questions and support needs
  • Must be legally authorized to work in the United States

Education and Experience:

  • Bachelor’s degree in a relevant subject or suitable experience in a Quality/Regulatory role
  • Excellent knowledge of ISO 13485, CE and FDA requirements, with experience working in a manufacturing setting.
  • Proven track record of preparing for and managing successful quality audits and inspections.

Physical Requirements:

  • Prolonged periods sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times.
  • Travel up to 10% of the time.

Full-Time/Part-Time Full-Time  
Division Extron Company  
Exempt/Non-Exempt Exempt  
Location Extron - Plymouth  
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.  

This position is currently not accepting applications.

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