Quality Engineering Technician

SMC•Santa Rosa, CA

4d•$32 - $35

About The Position

The Quality Engineering Technician provides quality-system and documentation support for validation-cage materials, retain-sample controls, data packages and templates, CAR/CAPA product containment, inspection-instruction updates, and device history record (DHR) reviews supporting complaint investigations or shipment release. Working under designated Quality leadership and within delegated authority, the technician maintains accurate material status, segregation, traceability, and records; identifies documentation gaps; and routes issues and required approvals to the appropriate Quality representative.

Requirements

An associate or bachelor’s degree in quality, engineering, life sciences, manufacturing, or a related field; alternatively, a high school diploma or equivalent with at least 2–3 years of Quality Assurance experience.
Working knowledge of good documentation practices and the ability to review quality records, data packages, documentation, DHRs, inspection instructions, and CAR/CAPA containment documentation for completeness, accuracy, and traceability.
Ability to maintain controlled material and records, including validation-cage inventory, retain samples, containment status, and authorized release documentation.
Strong attention to detail, organization, and follow-through, with the ability to manage priorities, communicate status clearly, and promptly escalate missing, unclear, or overdue information.
Proficiency in Microsoft Excel, Word, and Outlook.
Ability to follow approved procedures, document-control requirements, and written and oral instructions in English.
Ability to meet the stated physical demands, including occasionally exerting up to 50 pounds of force, frequently up to 20 pounds, and constantly up to 10 pounds; performing specified movements and visual tasks; and working under the listed environmental and hazard conditions.

Nice To Haves

Experience in medical-device manufacturing or another regulated manufacturing environment.
Familiarity with ISO 13485, FDA quality-system requirements, and good documentation practices.
Experience reviewing data packages and DHRs, and maintaining MRB lists, validation-cage materials, retain samples, CAR/CAPA containment records, and inspection instructions.
Experience with electronic quality systems, document-control workflows, inventory or status logs, and controlled templates.

Responsibilities

Manage the validation cage by maintaining accurate material status and traceability; release or move material only with documented authorization from Quality Engineers.
Maintain retain-sample controls by logging, organizing, retrieving, and disposing of retained product in accordance with approved procedures and retention requirements.
Review quality data packages for completeness, accuracy, traceability, required records, and approvals against the applicable approved template.
Prepare data-package documentation, maintain and update data-package templates through the controlled-document process, and route discrepancies for correction.
Perform and document product-containment activities associated with CARs and CAPAs, including identifying, locating, segregating, and controlling affected product.
Collaborate with Quality Engineers to draft, redline, and update inspection instructions to reflect approved requirements and current practices.
Review device history records (DHRs) for completeness, legibility, accuracy, traceability, required entries, and approvals to support complaint investigations or shipment release.
Analyze data generated by Quality Technicians before sharing it with Quality Engineers.
Collaborate with Training Quality Inspectors.