Job Description

What Quality Engineering contributes to Cardinal Health Quality Engineering is responsible for product and service quality planning, evaluation, and control. Works cross-functionally in the development and implementation of prevention-based methodologies used in design, manufacturer, test, sustainability and correction of products and services. The Opportunity

• This position is remote and works out for our Singapore Cardinal Health Location.

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
• Ensure that products compliance to ISO 13485 and 21 CFR 820 Quality system regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.

• Involve in continuous improvement activities.
• Identifies and implements data analysis, system conformance and ensure finished goods meet standards and specifications, implement and drive changes were needed.
• Analyze quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvement.
• Participate in the creation or modification of activities such as Design Input, Design Output, Design Verification, Design Validation, Risk Management files, Critical to quality Matrix, Mechanical Drawing, Bill of Materials, Complaint Analysis, Review of Clinical Documents, Label Reviews, Standard Gap Assessment, Biocompatibility Risk Assessment, Risk Management File Review.
• Work closely with Research and development, Regulatory, Medical Affairs, Supplier, Audit, CAPA and Program Management team.
• Perform activities related to Risk Management Plan, Hazard Identification Worksheet, Risk Analysis Chart, and Risk Management Report
• May contribute to the development of policies and procedures.
• May require travelling to design site or to manufacturing site as needed.

• Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.
• Complete task independently after receiving general guidance on new projects.
• Perform other duties as assigned.

• Bachelor\xe2\x80\x99s degree in engineering or related disciplines preferred
• At least 3 years of related experience required.
• Working knowledge of Design control and Risk management in an FDA regulated industry.
• Understanding of federal, state, local and industry standards, guidelines, and regulations (i.e., AAMI, ANSI, GMP,21CFR820 and ISO 13485).
• Excellent attention to details and organizational skills.
• Statistical process controls knowledge including sampling plans, charts, DOE, ANOVA, t-tests etc.
• Knowledge of basics engineering or technical drawing (i.e., Mechanical and Assembly drawing)
• Excellent interpersonal skills Ability to collaborate cross-functionally with Engineering, Manufacturing, Supplier Quality, etc.
• Strong analytical and problem-solving skills.
• Excellent technical writing skills. Proficient with Microsoft office or related software and applications.
• ASQ or BSI or related Certifications are a preferred.