Quality Systems Specialist

4 weeks ago

Aurora, United States CareerBuilder 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 ( Have and maintain a valid passport
Working knowledge of Microsoft Office suite of applications.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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