Quality Engineer

American Packaging Corporation•Rochester, NY

85d•Onsite

About The Position

The Quality Engineer at American Packaging Corporation (APC) is responsible for customer advocacy, transforming customer feedback into actionable opportunities, and driving customer satisfaction through data-driven analysis. This role champions the Integrated Business Management System (IBMS), maintaining certifications (ISO9001, 14001, FSSC), providing training, and developing procedures. The engineer will lead and conduct audits, maintain statistical tools for continuous improvement, and act as a change agent for quality-related projects. Additionally, the role applies project management and technical expertise to deliver Validation program goals, interacting with customers to meet their expectations. Key responsibilities include managing the customer complaint program, monitoring and reporting quality data, executing performance reviews, and providing backup for Quality Supervisors and technicians. Travel may be required to collaborate with customers. The role drives continuous improvement using lean six sigma and quality tools, recommends capital projects, and uses statistical software for data analysis. The Systems aspect involves overseeing IBMS implementation, maintaining manuals and procedures, managing the internal audit and corrective action systems, hosting external audits, and collecting/analyzing quality data for KPIs. The Validation aspect includes managing the scope, schedule, and reporting of validation activities, writing and executing IQ/OQ/PQ protocols, managing change control and calibration processes, providing hands-on support for problem-solving, and participating in risk analysis activities like FMEA.

Requirements

Bachelor's degree (B. A.) from a four-year college or university in Systems, or a Bachelor's degree in science, mathematics, or engineering for Customer & Validation roles.
Two years of related experience and/or training, or an equivalent combination of education and experience.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to utilize descriptive statistics (average, variation, standard deviation) to analyze data and support process control and capability analysis.
Ability to create and interpret control charts, histograms, pareto charts, and scatter diagrams.
Ability to develop statistically appropriate sampling plans.
Ability to use and learn statistical analysis software.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Regularly required to sit (Systems).
Frequently required to talk or hear (Systems).
Occasionally required to walk (Systems).
Frequently required to stand, use hands to finger, handle or feel objects, tools or controls (Customer & Validation).
Occasionally required to sit, reach with hands and arms, stand, walk, stoop, kneel, crouch or crawl and climb or balance (Customer & Validation).
Regularly required to hear (Customer & Validation).
Manual lifting not to exceed 50 lbs.
Specific vision abilities required include close vision, distance vision, color vision, and the ability to adjust focus.
Must be able to taste/smell.

Nice To Haves

ASQ certification is a plus (Systems).
ASQ certification is preferred (Customer & Validation).
Demonstrated use of Minitab or JMP is a preferred skill (Systems).

Responsibilities

Champion customer advocacy and transform the Voice of the Customer into actionable opportunities.
Drive customer satisfaction through data-driven analysis for prioritization of corrective measures and improvement opportunities.
Champion the Integrated Business Management System (IBMS), maintain certifications to ISO9001, 14001, FSSC, and other standards as required.
Provide training and write procedures and processes to support IBMS development.
Lead and undertake audits across all areas of the business as well as across the supply chain.
Maintain statistical tools for continuous quality and profit improvement projects.
Lead and drive improvement actions from audits, customer complaints, and continuous improvement.
Act as the change agent for quality related projects.
Apply project management and technical expertise to successfully deliver Validation program goals and outcomes.
Manage the customer complaint program, including associated return and credit authorizations.
Lead a team to identify root causes, implement corrective actions, and mitigate future quality risks.
Communicate effectively with customers regarding complaints and resolutions.
Monitor and report complaint and quality data and trends for area dashboards, operations review, and systems management review.
Execute formal weekly/monthly/annual Complaint Performance Reviews and report complaint status to the management team.
Provide backup for Quality Supervisors and Quality technicians.
Travel as required to work with customers, understand their concerns, and resolve issues.
Drive continuous improvement opportunities utilizing lean six sigma and the seven basic quality tools.
Recommend capital projects that improve Safety, Productivity, and Quality.
Write and improve manuals, standards, and procedures as needed.
Use statistical software and techniques for analysis of data including Process Capability (Cpk, Ppk), Statistical Process Control (SPC), and Design of Experiments (DOE).
Oversee effective implementation of the IBMS including applicable certifications.
Organize and manage the internal audit system and the corrective action system.
Host external audits, conduct internal audits and assist in training of other auditors.
Collect and analyze quality data and report on Key Performance Indicators (KPIs) to drive improvement.
Act as project leader for quality and continuous improvement activities and promote the use of improvement tools such as Six-Sigma, Error Proofing, and Measurement System Analysis.
Perform statistical analysis of data using Excel, JMP, Minitab or other statistical software tools.
Manage the scope, schedule, and reporting of Validation program activities for individual products and/or customers.
Ensure status, risks, and open issues are tracked and that all stakeholders are informed in a timely manner.
Write and execute IQ/OQ/PQ validation protocols and manage the associated deviation process.
Manage and lead the change control process, calibration process, and gage R&R process.
Provide hands-on support to manufacturing areas for problem-solving and long-term changes.
Participate in process failure investigations.
Maintain up-to-date knowledge of validation requirements, practices, and procedures and instruct other members of the site.
Support risk analysis activities, including design and process FMEA.
Facilitate team meetings as needed on in-depth process and product analysis, risk assessments, decision-making, and other evaluations related to the Validation program.
Assist in internal and 3rd party audits.