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Quality Process Engineer

Job in Danbury, Fairfield County, Connecticut, 06813, USA
Listing for: BioTalent Ltd
Full Time position
Listed on 2025-12-02
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer
Job Description & How to Apply Below

Overview

The Quality Process Engineer ensures supplier-provided materials and components meet high standards of quality, reliability, and manufacturability. This role develops and improves internal processes, manages supplier performance, and drives continuous improvement across the supply chain. Responsibilities include root cause analysis, corrective actions, PFMEA and Control Plan oversight, KPI monitoring, and management of the Production Part Approval Process (PPAP). Collaboration with cross-functional teams and suppliers ensures compliance with engineering requirements, regulatory frameworks, and industry standards such as ISO 9001, 14001, and 45001.

Responsibilities
  • Optimize workflows to support efficient, high-quality production.

  • Lead root cause analyses, corrective actions, and material review processes.

  • Develop and maintain PFMEAs, Control Plans, and quality documentation.

  • Monitor KPIs and drive data-based improvements.

  • Support prototypes, pilot builds, and product validation activities.

  • Ensure compliance with quality standards and regulatory requirements.

  • Partner with cross-functional teams and suppliers to resolve quality issues.

  • Facilitate supplier PPAP activities and approval.

Qualifications
  • Bachelor’s degree in engineering or related field.

  • 5+ years in a similar manufacturing quality role.

  • Six Sigma Green Belt (Black Belt preferred).

  • Strong problem-solving, organizational, and communication skills.

  • Proficiency with standard office software.

  • Willingness to travel up to 20%.

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