SQA Services - Quality Engineer
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Requirements
• Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing, or equivalent) • Aerospace, medical device, or regulated manufacturing environments • Supplier quality or process engineering • PFMEA, Control Plans, PPAP • Statistical analysis and process capability • Deep understanding of: • Failure mechanisms and risk analysis • Manufacturing processes (machining, forming, assembly) • Strong knowledge of: • AS9100 / ISO 9001 / GMP (as applicable) • AIAG Core Tools (PFMEA, MSA, SPC) • Ability to interpret: • Engineering drawings and specifications • Inspection and test data • Critical thinking and technical rigor • Ability to challenge supplier assumptions constructively • Strong written communication (client-facing reports) • Detail-oriented with systems-level thinking • $70 - $70 an hour
Responsibilities
• PFMEA and PPAP reviews • Assess completeness and technical accuracy of: • Failure modes and failure mechanisms • Cause-effect relationships tied to process steps • Severity, Occurrence, Detection rankings • Risk prioritization methodology (RPN or equivalent) • Challenge robustness of: • Preventive vs. detection controls • Verify alignment with: • Actual manufacturing process flow • Known risks identified during assessments (RCR, commodity review, FAI) • Ensure full linkage between PFMEA and Control Plan • Control methods (error-proofing, SPC, inspection) • Reaction plans for out-of-spec (OOS) conditions • Coverage of critical characteristics • Adequacy of inspection frequency and methods • Review statistical capability studies (Cp, Cpk) • Data integrity and collection methodology • Sample size and statistical relevance • Process stability (variation analysis) • Confirm readiness against thresholds (e.g., Cpk ≥ 1.33) • Develop structured engineering review reports including: • Gap assessment (Critical / Major / Minor) • Risk implications • Recommended corrective actions • Provide clear DTS readiness recommendation
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