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Summary

Under direction of supervisor, responsible for supporting new product development and sustaining Quality Engineering activities related to medical device hardware.

Essential Duties and Responsibilities

• Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and life cycle management.
• Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
• Support Risk Management activities for sustaining engineering projects.
• Support post market activities such as complaint investigation, complaint trending, CAPA, and FCA processes
• Assist in decision making for process improvement efforts
• Assist Renal manufacturing facility with design and supplier changes
• Preside as key quality participant in compliance audits and FDA/industry of health (MOH)/Notified Body inquiries

Qualifications

• Complaint Management
• CAPA and Field Corrective Actions
• Root Cause Analysis
• Risk Management/ FMEA
• Technical Problem Solving
• Statistical Analysis
• Design and Development Planning
• Development of Technical Requirements and Product Specifications
• Design Verification and Design Validation
• Design Reviews
• Design Transfer Activities
• Design History File Management
• Strong interpersonal/communication/influencing/negotiation skills.
• Strong analytical and problem-solving skills.
• Working knowledge of FDA Regulations
• Demonstrated ability to lead others within small project or investigation environments

Background and/or Experience

• BS engineering and 3-5 years in related Quality or Engineering field in the medical device industry.
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.