Senior Quality Validation Engineer (m/f/d)
Firmenname für PREMIUM-Mitglieder sichtbar
• Review, update and implement EU MDR technical documentation for BSI submission
• Provides support in developing and approves operating procedures, manufacturing control plans, pFMEA
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data
• Demonstrate proficiency in applying various tools and methods (for example, Process Excellence) to identify and realize process and business improvements
• Partners with Supply chain, R&D, RA and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed
• Ensures that Process Quality control plans are in accordance with product risk level and are consistently followed. Implements and/or maintains production and process controls using appropriate techniques (for example process capability measures, statistical process controls, process performance metrics)
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits
• A minimum bachelor’s degree in Engineering or related technical discipline with profound experience in quality is required. A Master’s or other advanced degree is a plus
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Experience working in both an FDA and European regulatory environment is preferred. Working knowledge of GMPs, QSR, 21 CFR 820, MDD, ISO13485 and ISO14971 is required. MDR is a plus
• Experience working on New Product Introduction process and Process Validation is required
• Fluency in English is required
• Fluency in French is required
• Dynamic Environment
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