Director of Quality -Medical Device - Danbury, Connecticut United States - 20913

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JOB DESCRIPTION

Job #: 20913
Title: Director of Quality -Medical Device
Job Location: Danbury, Connecticut - United States
Employment Type:
Salary: $130,000.00 - $175,000.00 - US Dollars - Yearly
Employer Will Recruit From: Regional
Relocation Paid?: Negotiable

WHY IS THIS A GREAT OPPORTUNITY?


Director of Quality - Medical Device Equipment Manufacturer

Growing & Profitable $3B Medical Device Manufacturer seeking talented Director of Quality for one of their large manufacturing sites.  This position will be responsible for managing a team 8 direct reports and up to 26 total employees in the quality department for this manufacturing site.  This person will direct the development, implementation and maintenance of the overall Quality Management System, which includes the functions of management controls, production and process controls such as supplier controls, in-process, final inspection and quality control.  Great work environment!

Opportunities for growth and advancement!

JOB DESCRIPTION

Growing & Profitable $3B Medical Device Manufacturer seeking talented Director of Quality for one of their large manufacturing sites.  This position will be responsible for managing a team 8 direct reports and up to 26 total employees in the quality department for this manufacturing site.  This person will direct the development, implementation and maintenance of the overall Quality Management System, which includes the functions of management controls, production and process controls such as supplier controls, in-process, final inspection and quality control.  Great work environment!

Opportunities for growth and advancement!

QUALIFICATIONS

  • BA/ BS technical degree
  • Must have 10+ years of related experience in an FDA regulated industry with at least 5 years recent experience with complex electronic, electro-mechanical and/or software imaging medical devices.   
  • Must have 5+ years managing a Quality Department in an FDA regulated industry
  • 5+ years in a leadership role with experience in employee engagement, performance management and talent development
  • Experience in hosting, supporting, and/or managing 3rd party audits (FDA, Notified Bodies, etc.
  • Knowledge of medical device Quality Systems Regulations (21CFR820), ISO 13485, EU and MDSAP 
  • Strong interpersonal skills, management skills, writing skills, presentation skills, good verbal and written communication skills including technical report writing.

Education:
University - Bachelor's Degree/3-4 Year Degree