Analyze data (not just run SPC charts), from a wide variety of sources, examine processes for true systemic root cause and then take the improvement project from concept through validation with little or no direct supervision.
- Ideal candidates will have “classic quality” quality background and have experience in: OEM/CM operations, Soldering, Braising/Welding, Mechanical Assembly, PCBAs and Lean manufacturing methodologies.
- Must be able to write Assembly and Configuration process instructions, design and map efficient process flows. Develops, evaluates, revises, and applies technical quality assurance methods to inspect and test in-process raw materials, production equipment, and finished products.
- Ensures products and processes are compliant with company standards and applicable government regulations.
- Must Troubleshoot on mechanical issues, supplier assembly issues, BOM/order problems and process flows.
- Participates in NPI, BOM structure/review, ECO review.
- Work with key suppliers as needed on product issues and tactical activities in support of providing consistent high levels of quality for purchased products.
- Assist the strategic SQA team in the selection, evaluation and management of suppliers.
- Participate in the product line Failure Analysis & Improvement performing regular quality data reviews & analysis. Measurement of the cost of non-quality in the factory,
- Drive root cause corrective or preventive action in design, test or manufacturing changes as appropriate to the situation.
- Performs final acceptance testing of products.
- A Bachelor’s Degree and 2+ years Quality Engineering experience in medical device and/or electronic assembly.
- ISO quality systems & internal auditing experience in Document control, Procedure writing, Employee training & certification, Product and process audits, Corrective and preventive action processes (5D/8D)