Quality Engineer - Design Assurance (5-10 yrs)
Looking for Design Assurance Quality engineer for US based Medical device company.
Please find JD below :
Responsibilities :
- Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices.
- Facilitate project quality activities addressing design and process verification / validation for new products and significant changes to existing products or processes.
- Facilitate design FMEA with the help of corporate functions, Lead in process FMEA, and conduct risk assessments in compliance with ISO 14971.
- Interface with corporate functions and Plant Quality Assurance for new products and significant changes to existing products or processes.
- Utilize parametric and nonparametric statistical analysis methods (ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, quality control charts, regression analysis,survival analysis, measurement system analysis, acceptance sampling ANSI/ASQ Z1.4 & Z1.9)to ensure products/processes are appropriately characterized and qualified prior to market release.
- Support review of Preproduction and First Article submissions from the plant and suppliers for new products and significant changes to existing products or processes. Participate in internal,supplier, and external regulatory agency audits / inspections as required.
- Develop Design History files for compliance to applicable Regulatory Standards and submissions.
WORK EXPERIENCE REQUIREMENTS :
- Number of Overall Years Necessary : 5-10
- Experience in medical device industry. Background in Quality Engineering and/or New Product Development/R&D
EDUCATIONAL REQUIREMENTS :
- Bachelor of Science / Engineering degree or higher preferably with Mathematics or Statistics as a subject
- ASQ Certified Quality Engineer and/or Operational Excellence is strongly preferred
- Six Sigma Black Belt certificate is a plus
SPECIALIZED SKILLS/TECHNICAL KNOWLEDGE :
- Experience with the FDA Quality System Regulation and ISO 13485 environment at a medical device manufacturer
- Project management training and experience.
- Experience with product development, design controls, and risk management for medical devices (ISO 14971).
- Desirable : Advanced statistics training and experience with plastic processing and/or automated assembly processes.
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