Quality Engineer

The Quality Assurance Engineer is responsible for supporting the Quality Department with all ISO 9001 related quality assurance functions. This role provides oversight of the requirements for the ISO 9001 Quality Management System (QMS) for our business model. The Quality Assurance Engineer is also heavily involved in and responsible for other quality management items across the company

ESSENTIAL FUNCTIONS

• Ensure the ISO 9001 QMS demonstrates its ability to consistently provide products and services that meet customer and statutory & regulatory requirements.
• Supports management in customer satisfaction through the effective application of the QMS system, including processes for & the assurance of adherence to customer and statutory & regulatory requirements.
• Collaborate with all departments within GPS and interact with regulatory agencies, customers, consultants, and vendors as related to the ISO 9001 QMS needs.
• Creating, updating, and control of documented information.

Manage documenting and retaining records for:

• Quality Policy; Scope of QMS; Management review.
• Process Control through Procedures, Work Instructions, & Specifications.
• Document control & revisions.
• Risks & Opportunities; Resources needed.
• Change management; Non-Conformance; Release of product.
• Calibration & maintenance and traceability; Monitoring & measurement of process.
• Corrective action; Process improvements. o Customer satisfaction & support; Post-delivery activity.
• Customer communication of product requirement.
• Internal audit; External/Customer audit(s); Supplier Quality management.
• Supplier scorecard review.
• Product identification & traceability; Retains/Preservation.
• Review and provide trend analysis metrics.
• Assist in supporting contract review.

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• Completion of customer document requests.
• Facilitate ISO 9001 quality-related investigations.
• Lead investigations of customer complaints regarding quality.
• Schedule and lead audits for ISO 9001 QMS (internal, external, customer).

EDUCATION & EXPERIENCE

• Minimum high school degree, Associates degree preferred in a related field
• Minimum 5 years’ experience with ISO 9001 Certified Quality Management System.
• Working knowledge of a manufacturing facility in an ISO 9001, AS9100, ISO 13485 or comparable standard
• Experience with the internal audit process.