Job Description

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives--where your purpose accelerates our mission.
Summary:
Lead and support PDLM deliverables review and approval.
Provide process consultancy to the R&D teams.
Essential Duties and Responsibilities:

• Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
• Assist in decision making for process improvement efforts.
• Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs,

verification, validation and design transfer strategies.

• Ensures that activities within the Product Development elements are performed in a manner consistent with the Design and Development Plan, Change Plan and Quality Planning.
• Support Risk Management activities for sustaining engineering projects.
• Support post market activities such as complaint investigation, complaint trending, CAPA, and FA
• Support global manufacturing facilities and associated manufacturing and supplier changes.
• Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries.
• Plan and Execute Internal audit program.
• Support global procedure implementations at site.
• Perform CAPA reviews and provide input to management reviews.
• Support Supplier quality activities and assist to maintain Approved Entity List for the Site.
• Support Quality Impact of purchases approval.
• Responsible for Quality Assurance of the Product Development and Lifecycle Management process.
• Responsible for the compliance and approval of PDLM records to Baxter procedures throughout the product lifecycle.
• Collaborate with regulatory affairs as needed to guide teams in meeting quality/regulatory requirements based on the regulatory plan/strategy or assessment.
• Collaborate with teams to provide strategy and guidance for meeting Baxter Requirements and External Quality Standards as appropriate.

Qualifications:

• Good interpersonal/communication/influencing/negotiation skills.
• Good analytical and problem solving skills.
• Working knowledge of FDA Regulations.
• Demonstrated ability to lead others within small project or investigational environments.
• Good technical overview of medical device verification, validation and test automation.
• Good understanding of 21 CFR Part 820, ISO 13485, EU MDD / EU MDR.
• Broad working knowledge of Medical Device Software Development Lifecycle and IEC 62304.
• Good understanding of medical device manufacturing process.
• Good Understanding of requirements for Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation.

Education and/or Experience:
BS engineering and 12 + years in related Quality or Engineering field in the medical products industry.
ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.
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