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Quality manufacturing engineer Austin Texas ref

ESR Healthcare
Austin, Texas, US
Full-time

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Experience level : Mid-senior

Experience required : 5 Years

Education level : Bachelor’s degree

Job function : Manufacturing

Industry : Electrical / Electronic Manufacturing

Compensation : View salary

Total position : 1

Relocation assistance : Yes

Summary :

The Quality Engineer designs, installs, and evaluates Quality Assurance (QA) process sampling systems, procedures, and statistical techniques.

Designs or specifies inspection and testing mechanisms and equipment. Analyzes production and service limitations and standards.

Monitors manufacturing process, fabrication, inspection, test and shipping activities. Recommends revision of specifications.

Formulates or helps formulate QA policies and procedures and conducts training on QA concepts and tools. Interfaces with all other engineering functions in Benchmark and with customers and suppliers on quality-related issues.

Responsibilities :

Assists with an analysis of routine contract requirements to determine what quality characteristics are to be controlled;

manufacturing, inspection, test equipment required; special controls of special processes; and special skills needed to ensure their proper application.

  • Validates SPC limits and controls. Audits process to ensure proper use and corrective action when out-of-control limit is reached.
  • Reviews the contract data item descriptions and requirements and assists with establishing the necessary controls to ensure compliance.
  • Creates control plans that align to customer, product, regulatory and sector requirements.
  • Participates in pilot runs and preproduction runs; assists with a basic analysis of results.
  • Reviews production and manufacturing specification processes to ensure conformance to drawings specifications and contract requirements.
  • Assists with the establishment of quality controls over all production processes and testing during the product cycle.
  • Participates in the generation and review of various types of specification, drawings and Acceptance Test Procedures.
  • Performs, when applicable, measurement capability and correlation studies to ensure continual adequacy and capability.
  • Monitors special test programs on assemblies, components, special processes, etc. due to design changes and / or problems developing during the manufacturing cycle.
  • Assists in inspection and testing of preproduction equipment to ensure compliance with drawings, specifications and contract requirements, prior to submittal, for customer acceptance.
  • Prepares summaries and analysis of evaluations, together with all pertinent charts, graphs, etc., under guidance of more senior engineers.
  • Ensures that records / files are initiated and maintained in all relevant documentation pertaining to Quality Assurance.
  • Performs Quality Audits to determine the effectiveness of the Quality Program and prepare audit reports.
  • Participates in the verification (First Article Configuration Inspection) of hardware versus drawing / specifications.
  • Prepares reports and corrective action documentation, under review of more senior engineers, in answer to Customer inquiries or complaints regarding inspection, test and production activities.
  • Drives corrective, preventive and closure actions for project issues related to quality and / or test nonconformance.
  • Develops and improves the site’s quality organization’s ability to perform complex problem solving to more effectively address customer complaints, service deviations and internal corrective actions.
  • Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
  • Drives / Uses Key Process Indicators (KPIs) to determine process effectiveness, identify areas for improvement, best practices and drive continuous quality improvement.
  • Supports cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement.
  • Writes verification and validation documentation and conduct required testing as needed.
  • Assists in driving the standardization of manufacturing processes of global customer accounts.

Skills :

  • Working knowledge of productivity tools, including Microsoft Office products and WebEx conferencing software.
  • 4 year Engineering or Technical degree.
  • Ability to support a 24 / 7 global business operation as required.
  • Understanding of and ability to use metrics and continuous improvement tools (e.g. Defect per Million Opportunities (DPMO), First Pass Yield (FPY), Defects per Million (DPM), Six Sigma, Failure Modes and Effects Analysis (FMEA), etc).
  • Demonstrates knowledge of domestic and international requirements, standards and regulations such as Food & Drug Administration (FDA) Quality System Regulation (QSR) Part 820, International Organization for Standardization (ISO), International Traffic in Arms Regulation (ITAR), International Automotive Task Force (IATF), etc.

Supports internal, corporate, notified body, FDA, customer and other audits.

5+ years of electronics manufacturing experience; Familiarity with advanced technologies and applications; Accredited certification preferred;

Master of advanced technologies and applications; Able to travel up to 10% of the time, including day and overnight as required.

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4 days ago
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