Sr Quality Engineer

The Senior Quality Engineer drives continuous improvement initiatives, ensuring adherence to quality standards, and mitigating risks throughout the product lifecycle. This role requires a strong understanding of quality management systems, statistical analysis, and problem-solving methodologies, along with excellent communication and leadership skills.

• Develop, implement, and maintain robust quality management systems
• Lead the development and revision of quality procedures, work instructions, and quality plans.
• Conduct internal and external audits to ensure compliance with quality standards and regulatory requirements.
• Support and participate in management reviews of the quality system.

• Lead and participate in Design for Manufacturability (DFM), Design for Assembly (DFA), and Design for Quality (DFQ) reviews.
• Develop and implement quality control plans, inspection methods, and test procedures for new and existing products.
• Perform root cause analysis and implement corrective and preventive actions (CAPA) for product non-conformances, customer complaints, and audit findings.
• Utilize statistical process control (SPC), capability studies, and other statistical tools to monitor and improve process performance.
• Oversee First Article Inspection (FAI) and Production Part Approval Process (PPAP) activities.
• Collaborate with engineering, manufacturing, supply chain, and other cross-functional teams to ensure quality at all stages.

• Participate in supplier selection and qualification processes.
• Conduct supplier audits and assessments to ensure compliance with quality requirements.
• Monitor supplier performance and drive corrective actions for supplier quality issues.
• Develop and implement supplier quality agreements.

• Lead and facilitate continuous improvement initiatives using methodologies such as Lean, Six Sigma, 8D, FMEA, etc.
• Mentor and train junior quality engineers and other team members on quality tools and methodologies.
• Drive a culture of quality awareness and continuous improvement throughout the organization.
• Analyze quality data and trends to identify areas for improvement and implement proactive solutions.

• Identify and assess quality risks throughout the product lifecycle.
• Develop and implement mitigation strategies to address identified risks.
• Participate in risk management activities (e.g., FMEA, Control Plans).

• Prepare and present quality reports, metrics, and analyses to management.
• Maintain accurate and thorough quality records.
• Ensure proper documentation of all quality-related activities.

All other duties as assigned.

• None.

• None.

• Work environment is one of a professional office environment connected to a manufacturing facility.
• This role would require the ability to sit for extended periods of time and work on a PC.
• There would be times where the person would need to be able to walk out on a manufacturing floor and would need to wear appropriate personal protective
• equipment as well as navigate possible uneven surfaces.
• Lifting/carrying of up to 20 pounds occasionally, bending, squatting, twisting rarely.
• The position is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work).
• Very limited exposure to equipment, machinery Powered Industrial Vehicle traffic and some chemicals.

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Industrial, Manufacturing) or a related technical field. Master's degree preferred.
• 5-8 years of progressive experience in a Quality Engineering role.
• Proficiency in quality tools and methodologies:
• Root Cause Analysis (8D, 5 Whys, Fishbone Diagram)
• Statistical Process Control (SPC), Process Capability Studies (Cp, Cpk)
• Failure Mode and Effects Analysis (FMEA)
• Control Plans
• Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP) / First Article Inspection (FAI)
• Lean Manufacturing and Six Sigma principles…