Quality Engineer - Manufacturing

Essential Functions

• Leads investigations into manufacturing production quality issues, including but not limited to nonconformances, line failures, and yield losses, to identify root causes and drive effective corrective and preventive actions (CAPA) by working cross functionally with different team.
• Partners with manufacturing teams to develop and maintain robust process controls that improve yield, reduce scrap / rework, and enhance product reliability.
• Develops, validates, and sustains in-process inspection methods, test procedures, and acceptance criteria.
• Establish and maintains statistical process control (SPC), measurement system analysis (MSA), and gage repeatability and reproducibility (GR&R) studies to ensure reliable data-driven decisions.
• Drives structured problem-solving activities to support manufacturing teams in troubleshooting quality issues. Utilizes data-driven tools and methodologies such as 5 Whys; Ishikawa diagram; Eight Disciplines (8D); and Define, Measure, Analyze, Improve, Control (DMAIC).
• Analyze trends in production data, nonconformances, and complaints to identify systemic issues and improvement opportunities.
• Leads customer complaint investigations from manufacturing perspective, collaborating with cross-functional stakeholders to provide manufacturing input, verify root causes, and implement process improvements that prevent recurrence.
• Assist Manufacturing Engineers with control plan and process validations (installation qualification (IQ), Operational Qualification (OQ), and performance qualification (PQ)).
• Participates in risk management activities to ensure process risks are identified and mitigated.
• Provide training and guidance to manufacturing staff on quality standards, defect prevention, and process control.
• Ensures compliance with ISO 13485, FDA 21 CFR Part 820, and company procedures through strong process monitoring and documentation.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications

Pay range : $71,000-$95,000 / yr. Exact compensation may vary based on skills and experience.

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