Quality Engineer

Overview

The Quality Engineer (QE) plays a critical, hands-on role in supporting active manufacturing operations, driving continuous improvement, and leading technical quality initiatives. Reporting to the Director of QA & RA, this self-directed engineer owns customer complaint investigations, CAPA execution, process validations (IQ/OQ/PQ), and quality engineering support for New Product Introduction (NPI). Operating with a high degree of autonomy, the QE collaborates closely with cross-functional teams (including Manufacturing Engineering, R&D, and peer Quality Engineers and QC technicians) to drive root-cause problem solving, defect reduction, and seamless product transfers into production..

Overview

The Quality Engineer (QE) plays a critical, hands-on role in supporting active manufacturing operations, driving continuous improvement, and leading technical quality initiatives. Reporting to the Director of QA & RA, this self-directed engineer owns customer complaint investigations, CAPA execution, process validations (IQ/OQ/PQ), and quality engineering support for New Product Introduction (NPI). Operating with a high degree of autonomy, the QE collaborates closely with cross-functional teams (including Manufacturing Engineering, R&D, and peer Quality Engineers and QC technicians) to drive root-cause problem solving, defect reduction, and seamless product transfers into production..

Responsibilities


General Responsibilities

• Performs work in a safe manner following all company safety rules and procedures.
• Commitment to Total Quality Leadership (TQL) through participation in quality improvement teams, cross-functional projects, and work groups.
• Understands and complies with all applicable requirements of the Company’s ISO, FSSC, cGMP, and other applicable quality systems as documented in the Quality Manual, System Procedures, and Work Instructions.
• Uses engineering data and sound technical analysis to identify and resolve quality issues.
• Maintains accurate, timely, and complete quality records and documentation in accordance with established procedures.

• Provides hands-on Quality Engineering support to Manufacturing, Manufacturing Engineering, Operations, and R&D to identify and resolve process and product quality issues.
• Applies Lean and Six Sigma tools methodologies (DMAIC, SPC, Pareto) to identify trends opportunities for defect reductions.
  
  Conduct hands-on root cause analysis on the shop floor for process variances, non-conformances, and line-stoppages, driving sustainable solutions to the source.

• Investigates assigned customer complaints, including review of manufacturing records, process information, test results, samples, and other relevant data.
• Performs root cause analysis and prepares clear, objective investigation reports and customer responses.
• Supports and manages assigned CAPAs resulting from complaints, non-conformances, audits, and process investigations.
• Works with cross-functional teams to implement corrective actions and verify their effectiveness.
• Monitors complaint and internal quality data to identify recurring issues and quality trends. Validation & Risk Management
• Supports, and when assigned, leads process, equipment, and test method validation activities, including IQ, OQ, and PQ protocols and reports.
• Applies risk-based principles to investigations, process changes, validation activities, and quality improvements.
• Supports development and maintenance of quality documentation, including procedures, work instructions, HACCP documentation, inspection criteria, and process controls.
• Develops or supports appropriate sampling plans, inspection methods, and testing requirements.
• Serve as Quality Engineering representative on cross-functional NPI teams, collaborating with R&D and Manufacturing Engineering for product design reviews and transfer into commercial manufacturing.
• Establish quality requirements, inspection criteria, and critical-to-quality (CTQ) specifications for incoming raw materials, sub-assemblies, and new products during development phases.
• Collaborates effectively with Quality, Manufacturing Engineering, R&D, Operations, and QC laboratory technicians to resolve quality issues and achieve quality objectives.
• Supports supplier quality activities, including supplier investigations, material qualifications, and supplier-related non-conformances when technical Quality Engineering support is required.
• Communicates quality issues, project status, and recommendations clearly to cross-functional teams.
• Supports internal, customer, and regulatory audits as assigned.
• Assists the Director of Regulatory Affairs & Quality Group on special projects as required.
• Support company sustainability initiatives such as Scope 1/2/3 GHG calculations and life cycle assessments.
• Ensures procedures, systems and controls…