Senior Quality Engineer

Responsibilities: • Directs inspection plans for parts, components, and sub-assemblies received for production • Improves current measurement and inspection practices utilizing Design for Experiments, Capability Analysis, Tolerance Stack Analysis, Gage R&R, etc. • Consolidates and organizes supplier quality performance metrics, associated data, and messaging for use during periodic supplier performance review meetings • Regularly reviews supplier performance with supply chain to identify and mitigate key quality issues • Actively lead in the continuous improvement of Biomeme’s QMS and assures compliance with regulatory requirements • Supports/leads Internal Audits, and takes actions as appropriate based on CAPAs, complaint investigations, negative trends related to nonconforming products/materials, etc. • Leads efforts, in cooperation with Manufacturing Engineering, to qualify and validate equipment, processes, and test methods • Leads and/or participate as a member of the Material Review Board to disposition nonconforming product/materials, and develop feedback on product/material quality for suppliers • Leads and teaches RCA tools such as 8D, 5-why, Ishikawa Diagram, to evaluate nonconforming parts/components/materials, etc. • Uses/initiates/manages CAPAs to manage/monitor important projects effecting product, process, and quality system • Provides technical and administrative support and guidance to direct and indirect reports • Mentors, coaches, and trains QEs and other staff in quality management principles, procedures and serves as a mentor and coach to quality staff to advance their careers • Works in cooperation with Manufacturing Engineering and R&D Engineering to create and maintain Design History Files/Technical Files/Risk Management Files for Biomeme products. • Updates dFMEAs and pFMEAs to align with advancements/updates to Biomeme products Required Experience • Work with all levels and functions within the company • Ability to organize and conduct multiple, parallel tasks • Excellent written and verbal communication • Understanding of quality system regulations (ISO 13485, 21 CFR 820, MDSAP, etc.) • Analytical skills for compiling and analyzing data • Knowledge of DOE, SPC, Gage R&R, and sampling plans • Computer and software skills • Ability to motivate others and improve efficiency • Knowledge of applicable statistics and data analytics • Continuous improvement principles and practices including Six Sigma Green Belt Certification, DMAIC, Value Stream Mapping, Kaizen, etc. • Six Sigma Black Belt a plus • Knowledge of GDP/GMP practices • Accredited Internal Auditor Certification is a plus • ASQ Quality Engineer Certification a plus Qualifications: • Bachelor’s degree in a technical discipline (Mechanical/Biomedical/Electrical Engineering), or equivalent, with a minimum of 3 years of experience in medical device quality assurance. • Minimum 5+ years’ experience in Manufacturing Engineering or Quality Engineering with preference having validation experience • Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971. • Understanding of required standards / regulations impacting Medical Devices. • Leadership ability and organization • Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work. • Must have experience in DOE, RCA, CAPA, and non-conformance investigations • Supervisory experience is a plus