Quality Systems Specialist

2 weeks ago

Aurora, United States Columbia Helicopters Full time

The Quality Systems Specialist is responsible for ensuring and maintaining the effectiveness of the quality management system, through auditing, CAPA and NC processes as required. The ideal candidate will have working knowledge and understanding of a QMS system requirements in a regulated environment (Aerospace preferred) and be able to support these areas as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Ensures quality and regulatory compliance in accordance with documented procedures for all aspects of company's QMS.
  • Maintains AS9100/AS9110 and regulatory compliance.
  • Independently scopes, plans, conducts, and reports on internal Quality System, Supplier and Production Verification audits.
  • Analyzes quality metrics to determine trends and provide summary for Management Reviews.
  • Assists with the Continuous Improvement processes.
  • Assists in/performs detailed investigations utilizing proven Root Cause and Corrective Action (RCCA) and structured problem-solving methodologies.
  • Assists with policy and process creation, monitoring and ensuring they meet all statutory and regulatory requirements.
  • Provides mentorship and support throughout the organization on best practices related to statutory/regulatory requirements and the company QMS.
  • Conducts oneself in accordance with Company's Core Values.
  • Other duties as assigned.
MINIMUM QUALIFICATIONS AND EXPERIENCE
  • Minimum 5 years of experience in a quality systems role (auditing, CAPA, NC). College degree preferred.
  • Formal understanding of auditing and Quality Systems (i.e., Audit Management, CAPA, Management Review, Quality Process/ Procedure, SMS).
  • Working knowledge of AS9100/AS9110.
  • Awareness of Title 14 of the Code of Federal Regulations with focus on Parts 21, 43, and 145.
  • Experience with Production Verification Audits, a plus.
  • Ability to properly identify and determine relevant objective evidence requirements for the support of audit findings.
  • Ability to work both independently and collaboratively in a team-oriented environment.
  • Excellent written and verbal communication skills with the ability to present ideas, concepts, and proposals to a wide range of audiences at all levels.
  • Experience with the use of precision measuring devices such as, calipers, micrometers, etc., a plus.
  • Ability to handle multiple tasks simultaneously in a fast-paced, deadline-driven environment.
  • Strong organizational skills with attention to detail.
  • Requires the ability to travel domestically and internationally (

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