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.

POSITION 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 assist 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; Assist with a basic analysis of results.
• Reviews production and manufacturing specification processes to ensure conformance to drawings specifications and contract requirements.
• Assist 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 improve 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/ Use 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.

QUALIFICATIONS

General Qualifications to be added to all ’exempt’ job descriptions:

Excellent written and verbal communication skills

Effective interpersonal skills

Effective multitasking skills and the ability to take on additional responsibilities as required

Effective organization and prioritization skills

Demonstrate high attention to detail

Ability to work with diverse groups

Demonstrates discretion, confidentiality, independent judgment and professionalism.

Ability to work with minimal supervision and guidance, exercising discretion and independent judgment.

Understanding of and ability to use continuous improvement tools.

Strong customer service and client focus

Working knowledge of productivity tools, including Microsoft Office products and WebEx conferencing software

Additional Specific Qualifications for position

• 4 year Engineering or Technical degree preferred or equivalent combination of education and experience as approved by executive management
• Proven ability to complete projects in a timely manner
• Ability to support a 24/7 global business operation as required
• Ability to work individually or in teams
• 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.

MUST HAVE

• Must be US Citizen
• Medical Device Manufacturing experience
• Printed Circuit Board Assembly & SMT experience
• 4-year Engineering or Technical degree preferred, or equivalent combination of education and experience as approved by executive management
• Proven ability to complete projects in a timely manner
• Ability to support a 24/7 global business operation as required
• Ability to work individually or in teams
• 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