Quality Engineer

Responsibilities

• Oversee effective implementation of the QMS, including any business accreditations
• Maintain the Quality Manuals and Quality Procedures and ensure contents are appropriate for business, operation, and customer requirements
• Cover the final inspection for all outgoing shipments
• Organize and manage internal and external audits and corrective action reporting, including training and guiding other auditors
• Create daily safety and visual inspection reports to send to HQ
• Report on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system
• Maintain the Standard Operating Procedure content and coordinate the issuing of these documents
• Review, collect, and analyze data on quality procedures to continuously improve plant targets using the 4M process
• Create, populate, or maintain databases for tracking validation activities, test results, or validated systems
• Communicate with regulatory agencies regarding compliance documentation or validation results
• Recommend resolution of identified deviations from established product or process standards
• Provide quality information to customer service team
• Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies

Qualifications

• Bachelor’s Degree in Engineering or related field or equivalent, relevant experience
• Laboratory or research experience preferred
• 1 to 3+ years of experience working in a manufacturing setting preferred
• Background with GD&T preferred
• Working knowledge of measurement and calibration
• Basic knowledge of electrical engineering
• Strong knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), and Failure Mode and Effect Analysis (FMEA)
• Knowledge of quality systems and Lean manufacturing
• Knowledge of IATF 16949 and ISO 9000