Quality Engineer II: QMS & Compliance Leader

Mitsubishi Chemical Advanced Materials Inc.; United States; On-site; USD 77,680 - 116,520; Full time

Job summary

Mitsubishi Chemical Advanced Materials Inc. is seeking a mid‑level Quality Engineer II to lead complex quality initiatives and mentor junior staff in a regulated manufacturing environment.

The role focuses on driving QMS improvements, managing audits, and supporting supplier quality while ensuring compliance with ISO9001, AS9100 and ISO13485 standards. Collaboration with engineering and production is key.

Qualifications

• Bachelor’s degree in Engineering or technical field required.
• 4–7 years of progressive quality experience in a regulated manufacturing environment.
• Experience with CAPA, MRB, RMA and QMS documentation.
• Willingness to travel up to 25% and wear PPE.

Responsibilities

• Lead cross‑functional root‑cause investigations and manage CAPAs.
• Oversee QMS administration and ensure ISO9001/AS9100/ISO13485 compliance.
• Own key QMS subsystems like document control and supplier quality.
• Lead internal audits and mentor auditors.
• Develop Quality Plans, Control Plans, and Process Validation protocols.
• Lead FAI and PPAP for new product introductions.

Skills

CAPA

Root cause analysis

QMS processes

Audit programs

FMEA

SPC

MSA

DOE

8D

Quality tools

Education

Bachelor's degree in Engineering or related field

Associate's degree with quality engineering experience

Tools

Quality management software

Audit software

Statistical analysis tools

Job description

Mitsubishi Chemical Advanced Materials Inc. is seeking a mid‑level Quality Engineer II to lead complex quality initiatives and mentor junior staff in a regulated manufacturing environment.

The role focuses on driving QMS improvements, managing audits, and supporting supplier quality while ensuring compliance with ISO9001, AS9100 and ISO13485 standards. Collaboration with engineering and production is key.