The Quality Engineer is responsible for developing and maintaining control plans with defined reaction plans, measurement methods, and process control actions that control and improve the blown film extrusion process within the quality system. This is a hands-on role with a daily presence in the manufacturing environment, working directly with operators, extrusion technicians, and maintenance personnel. The Quality Engineer leads cross-functional teams in root cause analysis and corrective action implementation, applies project management discipline to quality initiatives, and serves as a communication bridge between production, quality, and customer-facing teams. General Responsibilities: - Develop, implement, and maintain control plans for extrusion and converting processes, defining key process and product characteristics, specification limits, measurement methods, sampling frequency, and documented reaction plans that specify exactly what operators and technicians must do when a process goes out of control or nonconforming conditions are detected.
- Define and validate measurement methods for each control point, including gauge measurement, film property testing (tensile, dart drop, seal strength, COF, elongation), and visual defect criteria, including proper gauge selection, measurement technique, and Gage R&R to ensure measurement system integrity.
- Audit control plans on the production floor, verify they reflect actual practice, and update them as processes, materials, and equipment change so they remain living documents within the quality system.
- Train operators and technicians on control plan requirements so process control actions are executed consistently at the point of work.
- Lead cross-functional root cause analysis teams using structured methods such as 5-Why and fishbone diagrams, and own corrective and preventive action implementation from investigation through verification of effectiveness.
- Translate root cause findings into updated control plans, reaction plans, and work instructions so lessons learned become permanent process controls.
- Lead and manage quality-focused projects (scrap reduction, gauge variation reduction, complaint elimination, new product launches, capability improvements) using structured project management practices: charters, scope, milestones, resource planning, risk assessment, and stakeholder communication.
- Maintain a visible, daily presence in the manufacturing environment, observing runs at the extruders, conducting first-piece and in-process inspections, and auditing process parameters against control plans.
- Communicate quality performance, project status, and investigation findings across all levels of the organization, from line operators to executive leadership, and prepare quality reports and customer-facing corrective action responses.
Job Tasks - Develop control plans with reaction plans that shift the plant from detection to prevention and process control, ensuring out-of-control conditions trigger defined containment, correction, and escalation.
- Establish and document measurement methods for key process and product characteristics and confirm measurement system capability through Gage R&R and MSA.
- Perform hands-on product testing and evaluation: gauge profiles, tensile properties, dart drop impact resistance, seal strength, COF, elongation, and visual defect analysis.
- Lead containment efforts for nonconforming product, including quarantine, disposition, and scrap/hold decisions.
- Lead root cause analysis with production, maintenance, and process engineering personnel; challenge assumptions and push investigations beyond surface-level explanations.
- Track corrective actions to closure, verify effectiveness with data, and escalate systemic risks to the Quality Manager.
- Charter, plan, and drive multiple concurrent quality projects to on-time completion with verified, data-backed results; report progress, barriers, and decisions needed in plant meetings.
- Apply Six Sigma methodology (DMAIC) and lean tools to drive continuous improvement in scrap, downtime, capability, and customer complaints.
- Support internal and external audits (SQF, customer audits, and applicable regulatory requirements) and participate in PPAP activities for new product launches, including quality plans and control plans for new film structures and resins.
- Support supplier quality activities, including incoming resin and additive inspection and supplier corrective actions.
- Train and mentor production personnel on quality standards, defect recognition, measurement techniques, and problem-solving methods.
- Foster a culture of quality ownership on the floor where operators feel empowered to raise concerns.
Knowledge and Skills: - Five or more years of quality engineering or quality-focused experience in a manufacturing environment; blown film extrusion, film converting, or polymer processing strongly preferred. A Bachelor's degree is valued but not required and may be substituted with equivalent experience and demonstrated results.
- Demonstrated experience developing control plans with defined reaction plans and implementing measurement methods within a quality management system.
- Demonstrated experience leading root cause analysis and corrective action teams using 8D, 5-Why, or equivalent structured methodology.
- Working knowledge of quality tools and systems, including control plans, FMEA, MSA/Gage R&R, corrective and preventative action management, and process capability analysis.
- Project management skills: ability to charter, plan, resource, and drive multiple projects to on-time, verified completion.
- Six Sigma certification (Green Belt or Black Belt) or equivalent demonstrated Six Sigma project experience preferred.
- Familiarity with SQF and FDA food-contact compliance; experience with customer-specific requirements in food, medical, or industrial packaging markets preferred.
- Strong critical thinking, communication, and team leadership skills, with the ability to lead cross-functional teams where members do not report directly to this role.
- Comfortable working hands-on in a plant environment around operating extruders, hot equipment, and winding lines; able to lift up to 50 lbs. occasionally and be present on the manufacturing floor for the majority of the shift.
|