Quality Assurance Manager--Colorado

Reference Number: 2697D
Location: Colorado

Respond with resume to dab@photonicsgrp.com

 

The Quality Manager will be responsible for supporting manufacturing process improvements, making a significant contribution to the strategic goal of quality improvement and manage Document Control, IQA and RMA departments.  This role will also lead continuous improvement efforts aimed at meeting quality, cost, and on-time delivery while meeting customer expectations and supplier quality management. This role is also responsible to support and maintain and site Quality Management System to meet ISO9001:2008, FDB’s QSR(Quality System Regulations as reference by FDA) and ISO 13485:2003 requirements.

Education-Experience:

  • BS in Electrical, Industrial or Mechanical Engineering preferred or Associate degree with five+ years experience in a manufacturing and/or regulatory environment is preferred.
  • Formal training in statistical techniques in a manufacturing environment with Six Sigma training and certification highly desired.
  • Ability to take responsibility for quality of all products including assembly, testing and yields.
  • Understanding and familiar with design control processes including: design history files, manufacturing process instructions, MRB, failure analysis and corrective/preventive actions and verification testing per cGMP requirements / FDA QSR / ISO 9001/ ISO13485/ ISO 14971 is highly preferred.
  • Knowledge and experience with continuous improvement techniques such as Lean Enterprise, Six Sigma, Kaizen, etc. is desirable.
  • Experience in NPI process management and product quality planning is a big plus
  • Experience working with supplier quality management is desirable.
  • Excellent oral and written communication skills.
  • Proficient in MS Office and MS Project is preferred.
  • ASQ certified Quality Engineer and or ASQ certified Black Belt is beneficial

This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR).   All applicants must be U.S. persons within the meaning of ITAR.   ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

The Photonics Group

Call us at 919 479 1941