Quality Engineer II; Mitsubishi Chemical Advanced Materials

Quality Engineer II

The Quality Engineer II (QEII) 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 (ISO 9001, AS9100, ISO 13485).

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 ISO 9001, AS9100, and ISO 13485.

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 FAI and PPAP process 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 Engineer I 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.

Bachelor's degree in Engineering, Quality, or technical field required. Associates 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 ISO 9001, AS9100, and ISO 13485 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 (e.g., 5 Whys, 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.

The salary range for this position is $77,. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.

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