Katalyst Healthcares & Life Sciences Hiring for Quality Engineer at Athens, TX Full Time

• Lead Quality Assurance in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169.
• Manage validation activities as established by USFDA CRF 820, ISO 13485, and MHLW Ministerial.
• Ordinance 169, and other regulatory bodies as required.
• Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the design transfer and manufacturing of products.
• Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) leading or participating in efforts and cross-functional teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• May be responsible for creating risk analyses and FMEA’s.
• Collects and analyzes process defect date for product/process improvement efforts (e.g., scrap, nonconforming product, customer complaints) by systematically gathering metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
• Owns and drives Nonconforming Event and Correction and Preventative Action investigations.
• Supports continuous improvement activities, NCEPs, CAPA, and Lean initiatives.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support internal and external regulatory audits.

Education & Experience:

• Bachelor’s Degree in Engineering, Biomedical Engineering, or related science discipline.
• Minimum of 5 years of experience in Quality Engineering within a Medical Device Manufacturing environment.
• ASQ CQE certifications a plus.
• Six Sigma Certified Green or Black Belt is a plus.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations: Ability to understand other medical device regulations and standards.
• Experience in nonconforming material and CAPA methodologies/systems preferred.
• Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
• High sense of urgency and commitment to execution.
• Applies continuous improvement principles in the development of the quality system.
• Driven, energetic, self-assured professional with high personal integrity.
• Knowledge of analytical techniques and statistical analysis.