Quality Engineer II — QMS & CAPA Leader

Mitsubishi Chemical America; Mesa (AZ); On-site; USD 77,680 - 116,520; Full time

Job summary

Mitsubishi Chemical Advanced Materials Inc. is seeking a Quality Engineer II to lead complex quality initiatives and mentor junior staff in a regulated manufacturing setting. You will serve as a technical SME for core QMS processes and drive improvement across manufacturing and supplier operations.

Responsibilities include leading cross-functional CAPAs, maintaining ISO 9001/AS9100/ISO 13485 compliance, owning key QMS subsystems, and guiding internal audits. Travel up to 25% may be required.

Qualifications

• Bachelor’s degree in Engineering, Quality or a technical field (or associate degree with 3+ years QE).
• 4–7 years of progressive quality experience in a regulated manufacturing environment.
• Proficiency in ISO 9001, AS9100 and ISO 13485 requirements and audit protocols.
• Experience with CAPA, MRB, RMA and QMS documentation.
• Lean or Six Sigma Greenbelt certification desired.

Responsibilities

• Lead cross-functional root-cause investigations and high-impact CAPA teams.
• Maintain and improve the QMS for ISO 9001, AS9100, ISO 13485 compliance.
• Own QMS subsystems: document control, calibration, audit program, supplier quality.
• Lead internal audits and train auditors.
• Develop Quality Plans, Control Plans and Process Validation protocols.
• Lead FAI and PPAP for new product introductions and changes.
• Support RMA process, ensure timely evaluation and resolution.
• Conduct supplier assessments and manage supplier corrective actions.
• Analyze quality metrics and present executive summaries and dashboards.
• Support customer quality interactions, audits, data requests, issue resolution.
• Mentor QE I and Inspectors; coach on quality tools.
• Promote advanced quality tools (FMEA, SPC, MSA, risk management).
• Lead training on QMS procedures and quality tools.

Skills

Leadership

Project management

Root cause analysis

Quality Systems (QMS)

Auditing

Regulated manufacturing

Lean Six Sigma Green Belt

Education

Bachelor’s degree in Engineering

Associate’s degree with 3+ years QE

Tools

SPC

FMEA

DOE

MSA

Control Plans

8D

Job description

Mitsubishi Chemical Advanced Materials Inc. is seeking a Quality Engineer II to lead complex quality initiatives and mentor junior staff in a regulated manufacturing setting. You will serve as a technical SME for core QMS processes and drive improvement across manufacturing and supplier operations.

Responsibilities include leading cross-functional CAPAs, maintaining ISO 9001/AS9100/ISO 13485 compliance, owning key QMS subsystems, and guiding internal audits. Travel up to 25% may be required.