Quality Process Engineer

Job Title:

Quality Process Engineer

Job Description

The Quality-Focused Molding Process Engineer serves as the primary technical liaison between Manufacturing Engineering and Quality, providing subject matter expertise in Injection Molding, Extrusion Blow Molding, and Injection Blow Molding to ensure product conformance and customer satisfaction. This role focuses heavily on investigating customer quality complaints, executing corrective and preventive actions (CAPA), and driving systemic defect reduction while working cross-functionally to protect customers and maintain compliance.

The engineer owns the technical root cause analysis for molding-related quality issues and is accountable for ensuring that corrective actions are robust, validated, and sustained over time.

Responsibilities

+ Act as the technical lead for customer quality complaints involving molded components, processes, or materials.

+ Lead investigations using structured, data-driven methodologies such as 5-Why, Fishbone diagrams, and Fault Tree Analysis.

+ Perform statistical analysis and review statistical process control (SPC) data to understand process performance and variation.

+ Conduct process capability and variation analysis to identify improvement opportunities and ensure stable production.

+ Partner with Quality Engineering to define and implement effective containment plans for quality issues.

+ Support customer-facing complaint responses by providing clear, data-driven technical input and documentation.

+ Execute and document corrective and preventive actions (CAPAs) within the quality management system (QMS).

+ Ensure that corrective actions address true root causes, are properly validated, and demonstrate sustained effectiveness over time.

+ Identify recurring or systemic quality risks and proactively drive preventive improvements to reduce future defects.

+ Support regulatory, customer, and internal audits as the molding process subject-matter expert.

+ Develop, document, and maintain robust and capable molding processes that minimize defect opportunities and ensure consistent quality.

+ Establish and sustain stable process windows for Injection Molding, Extrusion Blow Molding (Accumulator and Continuous), and Injection Blow Molding.

+ Define critical process parameters, process controls, alarm limits, and escalation criteria to maintain process stability.

+ Support the development and maintenance of Control Plans, Reaction Plans, and risk-based process monitoring strategies.

+ Drive defect reduction projects using trends and insights from scrap data, nonconformance reports (NCRs), customer complaints, and audit findings.

+ Provide on-the-floor technical support for production issues driven by quality concerns.

+ Lead investigations into nonconformance reports (NCRs), deviations, and out-of-spec conditions related to molding processes.

+ Work closely with Manufacturing, Set-Up, Maintenance, and Tooling teams to correct quality escapes and resolve process instability.

+ Ensure rapid restoration of compliant production while maintaining all required documentation and traceability.

+ Balance production urgency with a strong focus on compliance and product quality in all decision-making.

Essential Skills

+ Demonstrated experience leading manufacturing-related quality investigations.

+ Deep technical expertise in molding processes, including Injection Molding, Extrusion Blow Molding, and Injection Blow Molding.

+ Evidence of successful CAPA implementation and verification of effectiveness.

+ Quality-first mindset with the ability to balance production urgency and compliance requirements.

+ Proven ability to work effectively across Engineering, Quality, and Operations functions.

+ Bachelor's degree in Engineering, preferably Mechanical, Chemical, or Plastics; equivalent experience considered.

+ At least 5 years of manufacturing engineering experience in an ISO-regulated environment.

+ Strong hands-on expertise in Injection Molding, Extrusion Blow Molding, and Injection Blow Molding.

+ Proven experience supporting customer complaint investigations, CAPA execution, and audit responses.

+ Strong understanding of SPC, process capability, and variation reduction techniques.

+ Experience working within formal quality management system (QMS) environments.

+ Familiarity with validation methodologies, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

+ Exceptional root cause analysis and critical thinking skills.

+ Ability to translate complex technical findings into clear, quality- and customer-focused communication.

+ Strong ownership mentality for product quality and regulatory or standards compliance.

+ Excellent organization, communication, and cross-functional collaboration skills.

+ Ability to influence stakeholders and drive change without direct authority.

Additional

Skills & Qualifications

+ Experience in quality engineering, process improvement, and continuous improvement initiatives.

+ Experience in…