Senior Design Quality Specialist

• 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

• 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

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

• 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)
• 401(k) Retirement Savings Plan (RSP)
• 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