Overview
QA GMP Consultant Jobs in Remote at Ardence Consulting LLC
Quality Manager / Representative – Minnesota Facility
The Quality Manager / Representative is responsible for ensuring that all electronic products manufactured meet internal quality standards, customer specifications, and applicable industry standards (such as FDA, IPC, ISO 9001, ISO 13485 and/or AS9100). This role leads the development and management of the Quality Management System (QMS), drives continuous improvement initiatives, and acts as the key liaison for customer quality audits and regulatory compliance in an electronics contract manufacturing environment.
Job Description
Plans, coordinates and directs daily activities of the quality team to ensure quality production of products consistent with ISO 9001 and AS9100 established standards.
Responsible for the design and implementation of an effective quality management team and system to ensure customer satisfaction, regulatory compliance and continuous improvement.
Establishes strategic direction in coordination with the General Manager for the Quality Department.
Support production department personnel to achieve company’s performance goals.
Lead, manage and develop all QA Staff engaged in inspection and testing activities to ensure continuous control over materials, facilities, products and processes.
Champion continuous improvement efforts and defect reduction initiatives to maintain an effective Quality Management System.
Perform root-cause analysis activities to identify effective corrective/preventive actions and process improvements.
Manage Plant quality metrics and utilize data driven analysis to track, trend and initiate continuous improvement activities to control cost of quality.
Manage CAPA, NCMR, ECN, Complaint and Document Control processes.
Participates in cross-functional problem-solving teams.
Manage the Quality Management System’s ISO 9001 & AS9100 registration, customer certifications and regulatory affairs.
Lead and participate in all internal and external quality audits.
Coordinate with vendors to ensure quality of all purchased materials/parts for Company.
Manage calibration and testing programs within the Company.
Requirements
BS or higher (Electrical, Mechanical or Chemical Engineering and/or Equivalent)
Minimum 10 years of Manufacturing, Quality Engineering experience in electronics manufacturing environment.
Hands on Experience in SMT/Through Hole circuit board assembly production, engineering or quality assurance, required.
Experience with cable/wire harness assembly a plus!
Ability to read, analyze and interpret production and quality documents, drawings, component specifications and related industry materials.
Experience in regulated manufacturing environment (i.e., ISO9001, AS9100, ISO 13485) and AS9100 interpretation and application for manufacturing.
Minimum of 3 years of quality auditing experience
Equal Opportunity Employer
VIRTEX is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, gender, sexual orientation, gender identity, gender expression, transgender, pregnancy, marital status, national origin, ancestry, citizenship status, age, disability, protected Veteran Status, genetics or any other characteristic protected by applicable federal, state, or local law.
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Title: QA GMP Consultant
Company: Ardence Consulting LLC
Location: Remote
