Job Requirements: 

• Bachelor-level degree in Engineering, Technical Field, or equivalent (advanced degree preferred).  
• Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.  
• Solid communication and interpersonal skills.  
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. 
• Advanced computer skills, including statistical/data analysis and report writing skills.  
• Experience working in a broader enterprise/cross-division business unit model preferred.  
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. 
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization. 
• Multitasks prioritizes and meets deadlines promptly. 

Job Responsibilities: 

• The Quality Engineer is responsible for the implementation and effectiveness of QA systems; including QA training, test & inspection equipment, Internal auditing, supplier approval/review, customer requirements review, Inspection planning, Support of customer and third-party audits, and proactive quality initiatives. 
• The Quality Engineer will also establish metrics to monitor the effectiveness of processes and adjust as necessary 
• Working experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).  
• Accountable for leadership, decision-making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.  
• Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.  
• Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities.  
• Maintain databases and record storage for QA systems. Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals. Lead meetings and communications for QA system information, concerns, and updates. 
• Lead and mentor others with QA data analysis, trending, and reporting.  
• High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.  
• Proficient as lead representative for presenting QA systems to internal and external auditors.  
• Investigate and resolve system nonconformances and concerns (defined during internal and external audits). As appropriate, leads in the completion of risk assessment, as related to QA systems.