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..

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.

Manufacturing Support & Continuous Improvement

• 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.

Customer Complaints & CAPA Execution

·        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.

New Product Introduction (NPI) & Project Support

• 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.

Cross-Functional Collaboration & Teamwork

• 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.

Other Duties and Support Requirements

• 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 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.

Qualifications:

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.

 

Base salary range 60-72K annually 

Annual bonus potential  5%