Quality Engineer

About the role

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

• Performs work in a safe manner following all company safety rules and procedures.
• Commits 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 and opportunities for defect reductions.
• Conducts 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.
• Serves 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.
• Establishes 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.
• Supports company sustainability initiatives such as Scope 1/2/3 GHG calculations and life cycle assessments.
• Ensures procedures, systems, and controls developed during the course of performing the Quality Assurance Engineering function are in conformance with current Good Manufacturing Practices (cGMPs) and the corporate Quality Manual.
• Represents the Company to customers and/or suppliers on quality-related matters when required.
• Prevents defects and/or possible defects in workmanship.

Requirements

Education & Core Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, Industrial) or a related technical scientific discipline required.
• 3+ years of hands-on Quality Engineering experience in a manufacturing environment.
• Experience working within a regulated quality system such as ISO 9001, ISO 13485, FSSC 22000, cGMP, or similar preferred.
• Experience in a manufacturing environment involving physical products, production processes, and in-process or finished-product inspection preferred.
• ASQ Certified Quality Engineer (CQE), Lean Six Sigma Green/Black Belt, or other related certifications are preferred but not required.

Technical & Engineering Competencies

• Quality Engineering: Demonstrated ability to investigate manufacturing and product quality issues, identify root causes, and implement effective corrective actions.
• Problem Solving: Working knowledge of structured problem-solving methods including 5-Why, Fishbone, 8D, DMAIC, or similar methodologies.
• Statistical Analysis: Working knowledge of SPC, process capability, sampling methods, and basic statistical analysis. Experience with Gage R&R, DOE, or other statistical tools preferred.
• CAPA & Complaints: Experience investigating, analyzing, and closing non-conformances, customer complaints, and corrective actions within a formal quality system.
• Validation: Familiarity with process and equipment validation principles, including IQ/OQ/PQ.
• Quality Systems: Ability to interpret and apply quality procedures, specifications, work instructions, and applicable regulatory requirements.
• Software & Systems: Proficiency with Microsoft Office, particularly Excel. Experience with Minitab, QMS, ERP, or SPC systems preferred.
• Technical Skills: Ability to read and interpret technical specifications, drawings, process documentation, and test results and to use common measurement and inspection equipment.
• Communication & Collaboration: Strong written and verbal communication skills with the ability to work effectively with Manufacturing, Engineering, R&D, Operations, QC, and other cross-functional teams.
• Ownership & Initiative: Self-motivated and organized, with the ability to independently manage assigned investigations and projects, prioritize work, meet deadlines, and escalate issues when appropriate.

Physical Demands

• Must be able to stand and walk for the duration of the shift.
• Occasionally lift or move objects up to 50lbs.
• Able to climb on and move barrels and boxes for sampling.

Work Environment

• Generally, works in an office/laboratory environment but may occasionally be required to perform job duties outside the typical office/laboratory setting.
• Normal manufacturing conditions in which safety observation must always occur.
• Protective equipment that might be required for different aspects of this position include safety shoes, safety glasses, and hearing protection in designated areas.

Pay

Base salary range $60,000–$72,000 annually. Annual bonus potential 5%.