myGwork - LGBTQ+ Business Community · 2 days ago

Quality Engineer

Hillsborough, NJ

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

Responsible for assuring all product specifications, and product regulatory requirements are met by manufactured and sourced items.

Interpret regulatory requirements and provide guidance for effective compliance, as well as providing coordination/support for programs and projects.

Provide oversight and management of various Quality Processes such as; Internal Audit Program, Corrective and Preventive Actions System, Change Control, Supplier/Co-packer Quality Management, Non-Conforming Material, etc.

Improve existing and develop new quality processes, writing and implementing associated procedures and other documentation.

Conduct investigations of undesirable trends in production processes performance and unplanned events, perform root cause analysis, and develop and implement corrective and preventive actions.

Conduct audits of suppliers and contract manufacturing firms in order to determine the effectiveness of their quality systems, as well as their capability to provide compliant goods and services. (May require frequent travel, including international.)

Provide technical guidance and facilitate problem-solving methodologies regarding quality-related issues.

Provide training and guidance to ensure compliance with Regulatory Requirements and Guidance, Standard Operating Procedures (SOPs), Departmental Operating Instructions, protocols and other governing documentation by Operations and Quality personnel.

Qualification

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SpcPfmeaDmaicLean manufacturingAcceptance samplingStatistical techniquesMetrologyCalibrationQuality controlIso standardsInternal auditCapaRisk managementMs office excelWordPowerpointMinitabQuality assuranceManufacturingProblem solvingAnalysisCommunicationOrganizationalTime managementChemistry background

Required

BS in Engineering Sciences required: such as Manufacturing, Industrial, Mechanical or related.

Knowledgeable or familiar in quality analysis tools such as SPC, PFMEA, DMAIC, Lean Manufacturing, Acceptance Sampling, etc.

Basic Statistical Techniques Skills, of Metrology and Calibration, Problem solving, analysis skills.

Familiar with quality control methods, tools and techniques, Good communication, organizational and time management, data analysis, reporting and presentation skills.

Requires Experience or Development in the area of ISO Standards, Internal Audit, CAPA, Risk Management, SPC.

Proficient in use of software such as MS Office Excel, Word, PowerPoint; Minitab.

Capability to learn new software such as QMS, SPC, Trackwise, InfinityQS/SPC, LEEDS, Master Control.

3+ years of Quality Assurance experience in manufacturing preferable.