Interested candidates can apply at rraj at divihn dot com for further information and discussions.
Description: The Product Quality Engineer applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products. The Quality Engineer will lead from a technical quality perspective to support product development, design change control and verification/validation activities. This position requires a functional understanding of FDA, ISO and Baxter Quality systems.
Essential Duties and Responsibilities:
• Ensure compliance with global quality systems and Regulatory requirements related to product and process Design Control, risk analysis, investigations, and CAPAs
• Support the sustainability and life cycle management of an existing product
• Perform design change control activities including impact assessments, reviews, and approvals
• Provide Quality Assurance support and guidance for verification and validation of product requirements
• Support risk management activities as they relate to post market surveillance
• Use statistical trending tools to monitor product complaint trends
• Take lead role in CAPA activities such as investigation, implementation, or verification of effectiveness
Qualifications for this Role:
• Must have experience or advanced training and demonstrate proficiency in statistical methods
• Completely proficient in relevant products or process development processes
• Good project management skills
• Extensive cross-functional team experience, including technical and non-technical work
Education and Experience
• Bachelors of Science degree in Engineering (discipline: electrical / mechanical / biomedical)
• 4-8 years’ recent relevant experience in the medical device industry.
• Previous experience working with Electromechanical IV pumps or syringe pumps, preferred.
• Experience in design control and strong knowledge of DHF and configuration management
• Working knowledge of medical device international standards
• Working knowledge of problem solving and statistical methods as applied to process and product quality preferred
• Product development experience pertaining to electromechanical devices preferred
• Software: Excel (pivot tables, v-lookups)*, Minitab*, Word, PowerPoint, Trackwise 8 (change control / compliant), & TCU
Local candidates are preferred