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.

• 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.

• 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…