Quality Engineer II (Mitsubishi Chemical Advanced Materials)

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

Company: Mitsubishi Chemical Advanced Materials Inc. Job Description: The Quality Engineer II is a mid‑level quality engineering role responsible for leading complex quality initiatives, supporting cross‑functional quality improvement efforts, and mentoring junior quality staff. Building on foundational knowledge, Quality Engineer II acts as a technical subject‑matter expert (SME) for core QMS processes and drives both compliance and systemic improvement across manufacturing and supplier operations. This role requires a strong technical background, independent project‑management capabilities, and the ability to influence cross‑functional teams in a regulated environment (ISO9001, AS9100, ISO13485).

What You Will Do

• Own/drive cross‑functional root‑cause investigations, manage high‑impact CAPAs, and oversee problem‑solving teams (e.g., 8D, DMAIC, or similar).
• Own day‑to‑day execution, administration and continuous improvement of the QMS to ensure ongoing compliance with ISO9001, AS9100 and ISO13485.
• Take ownership of key QMS subsystems (e.g., document control, calibration, audit program, supplier quality) and ensure compliance and continual improvement.
• Own internal audit program execution and train/mentor internal auditors.
• Develop and deploy Quality Plans, Control Plans, and Process Validation protocols in collaboration with engineering and production.
• Lead the First Article Inspection (FAI) and Production Part Approval Process (PPAP) for new product introduction and major engineering changes.
• Participate in and support the RMA (Return Material Authorization) process, ensuring timely evaluation, documentation, and resolution of returned products.
• Conduct supplier assessments and manage supplier corrective action processes.
• Analyze complex quality performance metrics and create executive‑level summaries and dashboards; present trends and actions at management reviews.
• Support and at times lead customer quality interactions, including audits, data requests, and issue resolution.
• Manage job duties and assigned quality projects with minimal supervision while meeting deadlines and maintaining accuracy.
• Mentor Quality EngineerI and Inspectors, offering technical guidance and coaching on quality engineering principles and tools.
• Drive the use of advanced quality tools such as FMEA, SPC, MSA, and risk‑management techniques across projects and processes.
• Lead or support internal training efforts on QMS procedures, standards, and quality tools.

What We Are Looking For

• Bachelor’s degree in Engineering, Quality, or a technical field required.
• Associate’s degree with at least 3 years working as a Quality Engineer acceptable.
• 4–7 years of progressive quality experience in a regulated manufacturing environment.
• Proficient in ISO9001, AS9100 and ISO13485 requirements, and internal/external audit protocols.
• Strong experience with CAPA, MRB, RMA and QMS documentation.
• Lean or Six Sigma Greenbelt certification desired.
• Demonstrated ability to lead quality improvement initiatives and manage small to medium cross‑functional projects.
• Strong familiarity with quality tools (SPC, FMEA, control plans, DOE, MSA, root‑cause analysis tools such as 5Whys, Fishbone, 8D, etc.).
• Experience leading audits (internal, supplier, customer).
• ASQ Certified Quality Engineer (CQE) preferred or ability to achieve within one year.
• Ability to travel up to 25% as needed.
• Must be able to wear personal protective equipment (PPE) as required.

Salary range: $77,680–116,520 (subject to geographic adjustment and additional factors such as scope, experience, education and market considerations).

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. Mitsubishi Chemical Advanced Materials Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email MCA‑[e-mail]. The law requires Mitsubishi Chemical Advanced Materials Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following link: Know Your Rights. Mitsubishi Chemical Advanced Materials Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. As a Federal Contractor, Mitsubishi Chemical Advanced Materials Inc. is required to participate in the E‑Verify Program to confirm eligibility to work in the United States.