Quality Engineer II

About the role

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).

Responsibilities

• 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.

Requirements

• 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.

Qualifications

• 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.
• 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.

Skills

• Strong familiarity with quality tools (SPC, FMEA, control plans, DOE, MSA, root cause analysis tools (e.g., 5 Whys, Fishbone, 8D, etc.)

Pay

The salary for this position starts at $77,680