Senior Design Quality Specialist

Baxter International Inc.•Round Lake, IL

About The Position

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.

Requirements

3-5 years related engineering/science/quality experience.
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.

Nice To Haves

Prior experience in product development, design and/or testing within medical device industry

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.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits