The Quality Coordinator supports their respective division in complying with applicable governmental, regulatory, and 3rd party certification requirements. This position focuses on improving the Business (Quality) Management System (BMS) by performing internal audits and maintaining excellent document control practices.
The Quality Coordinator collects, organizes, controls, monitors and distributes information related to quality and process improvement functions. This includes, but is not limited to, documentation related to the BMS, product conformity, change control, and corrective and preventative actions (CAPA).
This position generates and distributes reports to various users in the organization, as well as externally to customers and suppliers.
Requirededucation and/or experience
- Bachelor’s Degree or technical education certificate(s) in a quality related field, or a minimum of 3 years’ experience directly related to quality assurance
- Minimum 1 year of experienceauditing to ISO family Quality Management Systems standards
Essential job responsibilities:
• liable for the division’s internal and external document control, including checking authentic composition of documents for formatting, routing for approvals, revision control, issuing, submitting, and archiving.
• continues an archive of out of date pleasant department managed documents as required by way of the QMS the usage of GMN’s archive manner/system.
• Administers, coordinates, organizes, and documents data. This could encompass the file approval routings for superior Product satisfactory making plans (APQP), exchange manage, danger evaluation/FMEA, technique Validation protocols, and other data, as required.
- Conducts internal audits as directed by manager.
- Ensures audits are performed to schedule, are documented properly, and records are complete, including the initiation of corrective actions for any findings.
- Working with applicable managers, conducts methodical auditinvestigations according to best practices in our industry to determine root cause. Working with applicable managers, develops and implements corrective, preventive or improvement actions associated with quality system audits to meet quality, efficiency, and cost goals.
- Documents, files and maintains all external and internal audit records in appropriate system(s) as required by the QMS.
- Serves as coordinator/facilitator in documenting and monitoring CAPA related to the QMS using appropriate system software, ensuring that CAPA responses are responded to according to QMS requirements (time and content).
- A working understanding of the ISO family of standards, particularly ISO9001, AS9100, ISO13485.
- Understanding of Aerospace and Medical regulatory requirements (FAA, FDA/GMP) or the ability to gain and demonstrate an understanding of regulatory standards (attain and be able to apply the knowledge within 3 months of employment).
- Strong group facilitation and change management skills with an ability to communicate effectively and respectfully across the organization with all levels of staff.
- Highly proficient in Microsoft Office software, proficient with use of PC.
- Familiarity with, and ability to learn specific eQMS software applications and enterprise systems.
- Strong technical writing ability.
- Strong organizational, problem solving, and project management skills. Capable of planning and organizing work activities with a focus on efficiency
- Self-starter, with a proven ability to work independently with limited supervision.
- Experience in designing, documenting, and managing quality systems.
- Strong math and analytical skills, proficient at using analytical tools (charts, algorithms, etc.).
- Strong decision making skills.
- Ability to work under time constraints with occasionally shifting priorities.
- Lead Auditor Certification in one or more ISO certifications
- Auditor certification in at least one of GM Nameplate’s current certifications
- Strong grasp of LeanSix Sigma concepts
Job Type: Full-time
- Seattle, WA
- Understanding Aerospace and Medical Regulatory Requirements: 1 year
- Auditing ISO Systems: 1 year
- Six Sigma: 1 year
- ISO9001, AS9100, ISO13485: 1 year