Quality Engineer

Filtration Group Corp•Buffalo, NY

11d•$60,000 - $72,000•Hybrid

About The Position

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.

Requirements

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.
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.
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.
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.

Nice To Haves

ASQ Certified Quality Engineer (CQE), Lean Six Sigma Green/Black Belt, or other related certifications are preferred but not required.
Experience with Gage R&R, DOE, or other statistical tools preferred.
Experience with Minitab, QMS, ERP, or SPC systems preferred.

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.
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.