Process Engineer

Duration

12 months W2 contract with possibility of extension based on performance and depending on business needs

$90-$94/hr on W2

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 is heavily engaged in customer quality complaint investigations, CAPA execution, and systemic defect reduction, working cross-functionally to protect customers and compliance obligations. The engineer owns the technical root cause analysis for molding-related quality issues and is accountable for ensuring corrective actions are robust, validated, and sustained over time.

• Customer Quality Complaints, CAPA & Risk Mitigation (Primary Focus)
• Act as technical lead for customer quality complaints involving molded components, processes, or materials.

• Root Cause Analysis (5-Why, Fishbone, Fault Tree)
• Statistical analysis and SPC data review
• Process capability and variation analysis

• Define and implement containment plans
• Support customer-facing complaint responses
• Execute and document CAPAs within the QMS
• Ensure corrective actions address true root cause, are validated, and demonstrate effectiveness over time.
• Identify recurring or systemic quality risks and proactively drive preventive improvements.
• Support regulatory, customer, and internal audits as molding process subject-matter expert.

• Develop, document, and maintain robust, capable molding processes that minimize defect opportunities.
• Establish and sustain stable process windows for:
  • Extrusion Blow Molding (Accumulator & Continuous)
• Define critical process parameters, controls, alarm limits, and escalation criteria.
• Support development and maintenance of:
  • Control Plans
  • Reaction Plans
  • Risk-based process monitoring strategies
• Drive defect reduction projects using trends from scrap, NCRs, complaints, and audit findings.

• Provide on-the-floor technical support for quality-driven production issues.
• Lead investigations into NCRs, deviations, and out-of-spec conditions related to molding.
• Work closely with Manufacturing, Set‑Up, Maintenance, and Tooling to correct quality escapes and process instability.
• Ensure rapid restoration of compliant production while maintaining required documentation and traceability.
• The successful candidate will be highly organized, collaborative, and detail-oriented, with experience managing cross-functional projects in a regulated environment.

• Provide technical support for existing molds, molding processes, and equipment supporting current production products that are tied to an NCM.
• Lead mold debug and process optimization activities to restore or improve stability, capability, and product conformance.
• Support and execute revalidation or requalification activities (IQ/OQ/PQ or equivalent) for:
  • Process changes
  • Mold repairs or modifications
  • Equipment changes or refurbishments
• Execute and support IQ/OQ/PQ for new or modified molds, processes, materials, and equipment.
• Ensure validations adequately demonstrate capability, repeatability, and defect prevention.
• Support SMED initiatives while maintaining quality and compliance requirements.

• Author and maintain quality-critical engineering documentation, including:
  • Process Specifications
  • Set‑Up Sheets
  • Control Plans
  • Work Instructions
• Ensure molding processes comply with:
  • Applicable ISO standards
  • Internal QMS requirements
  • Regulatory expectations
• Drive standardization and best practices across molding operations.

• Use complaint, audit, and production data to prioritize improvement efforts.
• Lead Lean and continuous improvement initiatives with a quality-first mindset.
• Participate in Gemba walks, quality reviews, and KPI discussions.
• Prepare capital justification supporting defect prevention, risk reduction, and enhanced process control.
• Act as a visible quality advocate within Manufacturing Engineering.
• Exercise technical authority to recommend and implement molding process changes necessary to restore or protect compliance, in alignment with Quality and Manufacturing leadership.

• Reduction in repeat molding-related customer complaints.
• Timely closure and demonstrated effectiveness of molding-related CAPAs.
• Improved process capability (Cp/Cpk) on critical quality characteristics.
• Reduced scrap, NCRs, and defect escapes tied to molding processes.

• 5+ years manufacturing engineering experience in an ISO-regulated environment.
• Extrusion Blow Molding