Senior Design Quality Specialist

Responsibilities

• As Quality Reviewer performs document reviews to support design and labeling change controls.
• Collaborate with teams to provide mentorship for meeting Baxter QMS Requirements and External Quality Standards as appropriate.
• Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions.
• Facilitates small project teams as needed to accomplish team objectives.
• Supports Quality internal and external audits as the need arises.
• Applies DMAIC tools to investigate non-conformances and participates in (CAPA) related activities, including CAPA ownership.

Requirements

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 3-5 years related engineering/science/quality experience.
• Preferred: Prior experience in product development, design and/or testing within medical device industry
• Ability to travel up to approximately 10% as needed,
• Solid understanding of FDA Regulations, Design Controls and Change Control requirements.
• Display a technical understanding of engineering and product development principles and procedures.
• Possess basic understanding of DMAIC investigation tools.
• Familiarity with Minitab required.
• Experience in working with cross-functional teams, including technical and non-technical work.
• Ability to organize and present technical information with minimal assistance.
• Demonstrates solid organizational skills and ability to work independently.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
• #LI-RS1
• US Benefits at Baxter (except for Puerto Rico)
• Equal Employment Opportunity
• Baxter is an equal opportunity employer. Baxter evaluates qu

Benefits

Additional Information

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your role at Baxter This position is for the Design Quality Specialist supporting the Baxter Clinical Nutrition Medical Device disposables product platform. Provides design quality support to the sustaining product development team to ensure compliance of the required DHF deliverables, resulting in the development of safe and effective medical devices.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Baxter? Share your experience