A global manufacturing organization specializing in high‑precision engineered components for medical, industrial, and consumer applications is seeking a Senior Quality Engineer to drive quality excellence across new product introduction (NPI), manufacturing, and customer quality initiatives.
Key Responsibilities
Lead all QA deliverables for new product introduction and transfer projects, including inspection instructions, first article inspections (FAI), capability studies, MSA, PPAP documentation, and project qualification activities.
Manage non‑conforming product control, perform failure analysis, and drive timely and effective corrective and preventive actions (CAPA) using structured problem‑solving methodologies.
Handle customer quality matters, including complaints, RMA coordination, sorting, and rework activities, while ensuring clear communication with internal teams, suppliers, and customers.
Prepare and present quality performance reports and lead internal and customer quality review meetings.
Develop and execute Training Needs Analysis (TNA) and conduct training for quality technicians and inspectors on inspection criteria, methods, and updated quality requirements.
Support customer process audits, NPI qualification audits, and system audits; manage engineering change orders (ECO), documentation updates, and purging activities.
Oversee supplier quality management, ensuring compliance with RBA requirements and the Supplier Code of Conduct.
Perform additional duties as assigned by management to support continuous quality improvement.
Key Requirements
Bachelor’s Degree in a science‑ or engineering‑related discipline (e.g. Materials Science, Physics, Chemistry, or equivalent).
Minimum 3–5 years of hands‑on experience in Quality Assurance within a manufacturing environment.
Strong working knowledge of QC Core Tools, including APQP, PPAP, FAI, MSA, SPC/CPK, FMEA, Control Plans, and 8D problem‑solving.
Proficient in Minitab and experienced in data analysis and statistical reporting.Familiar with ISO 9001, ISO 14001, ISO 13485, and IATF 16949 standards.
Able to interpret part drawings, engineering specifications, and technical documentation accurately.
Strong analytical, problem‑solving, communication, and cross‑functional collaboration skills.