Senior Quality Engineer: Lead QMS & Audits

Mitsubishi Chemical Advanced Materials Inc.; United States; On-site; USD 88,000 - 110,000; Full time

Job summary

Mitsubishi Chemical Advanced Materials Inc. is seeking a Quality Engineer III to lead strategic quality initiatives, enhance the QMS, and ensure regulatory compliance across the organization.

You will act as deputy to the Quality Manager, drive audits, and champion continuous improvement that boosts customer satisfaction and business performance. You will mentor junior engineers, lead supplier quality programs, support design for manufacturability and process validation, and collaborate with

Qualifications

• Bachelor's degree in Engineering, Quality, or related field.
• 7+ years of progressive quality experience in a regulated manufacturing environment.
• Strong knowledge of ISO 9001, AS9100, ISO 13485 standards.
• Lean or Six Sigma Black Belt preferred.
• Proven success in leading audits, managing customer/supplier relationships, and driving measurable improvements.
• ASQ Certified Supplier Quality Professional (CSQP) or ability to obtain within one year.
• U.S. person (per ITAR/EAR requirements).
• Ability to travel up to 25%.

Responsibilities

• Assist QA Manager by leading meetings and supporting departmental planning.
• Drive QMS harmonization and standardization across sites.
• Lead site audits and regulatory inspections (ISO, AS9100, FDA if applicable).
• Define and track strategic quality goals and KPIs aligned with business objectives.
• Lead multi-disciplinary problem-solving for systemic issues (scrap, warranty returns, field failures).
• Develop and implement supplier quality programs, including audits and performance improvement plans.
• Mentor junior engineers and lead technical development sessions.
• Support DFM, PFMEA, and process validation during product development.

Skills

QA Leadership

QMS Management

ISO 9001/AS9100/ISO13485

Audits & Compliance

Lean / Six Sigma Black Belt

Regulated Manufacturing

Supplier Quality

DFM/PFMEA understanding

Education

Bachelor's degree in Engineering or related field

Tools

CSQP Certification

Job description

Mitsubishi Chemical Advanced Materials Inc. is seeking a Quality Engineer III to lead strategic quality initiatives, enhance the QMS, and ensure regulatory compliance across the organization.

You will act as deputy to the Quality Manager, drive audits, and champion continuous improvement that boosts customer satisfaction and business performance. You will mentor junior engineers, lead supplier quality programs, support design for manufacturability and process validation, and collaborate with