Quality Engineering Manager - Danbury, Connecticut United States - 20226

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JOB DESCRIPTION

Job #: 20226
Title: Quality Engineering Manager
Job Location: Danbury, Connecticut - United States
Employment Type:
Salary: $120,000.00 - $150,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Us Citizen, green card holder
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Quality Engineering Manager (Medical Device), Danbury, CT

Growing & Profitable $3B Medical Device Manufacturer seeking talented Quality Engineering Manager for one of their large manufacturing sites.  This position will be responsible for managing a team of Quality Engineers & Quality Control personnel to sustain manufacturing of our innovative products focusing on the production and process controls including capital equipment with both electrical systems and software.  This person will also be a part of driving continuous improvement.  Great work environment!

Opportunities for growth and advancement!

JOB DESCRIPTION

Growing & Profitable $3B Medical Device Manufacturer seeking talented Quality Engineering Manager for one of their large manufacturing sites.  This position will be responsible for managing a team of Quality Engineers & Quality Control personnel to sustain manufacturing of our innovative products focusing on the production and process controls including capital equipment with both electrical systems and software.  This person will also be a part of driving continuous improvement.  Great work environment!

Opportunities for growth and advancement!

QUALIFICATIONS

  • BS degree in an Engineering, Mechanical or Electrical preferred.  Masters preferred
  • ASQ Certified Quality Engineer preferred
  • Six Sigma Certification preferred
  • Excellent working knowledge of medical device regulations (21CFR, ISO 13485:2003, ISO 14971:2012 and Medical Device Directive
  • Must have 10+ years of engineering experience, preferably with capital equipment including process validation, with at least 5 years recent experience with complex electro-mechanical medical devices.
  • Must have strong knowledge of production and process controls in a FDA regulated industry.  Must have experience in a medical device manufacturing, with working knowledge of risk management.
  • Must have strong supervisor experience and mentoring and developing others
  • Must have experience with test methods and standards for the validation of manufacturing of medical devices.  Must be skilled in test plan development and root cause failure analysis and working knowledge of supplier quality management.
  • Strong verbal and written communication skills especially technical report writing.

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