Quality Technical Consultant M/F

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.

Within a section or department in the Quality organization, the Technical Quality Expert is responsible for results in terms of product quality, performance, safety, and conformance to regulations and Baxter quality policies.

Essential Duties and Responsibilities :

• Be the Quality Design Assurance Subject Matter Expert (SME) for Medical Device products. Function as a Quality team member for R&D and life cycle management projects and ensure activities meet design control and Quality system requirements.

• Interacts frequently with leaders and functional peer group of technical product experts.

• Knowledgeable on quality system procedures and ensures compliance to Quality Management System (QMS) elements. Understands and assures conformance to regulations.

• Drive effective analysis and action plan to product complaint trends and triggers.

• Lead root cause investigations and product improvements in collaboration with R&D, Contract Manufacturing Organization, and other functions. Drive the technical support for CAPA investigations relating to products

• Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements.

• Serves as a coach, trainer & supports development of more junior associates.

• May assist in monitoring and interpreting new Quality systems and regulatory requirements and provide guidance to the R&D organization to assure new requirements are established and implemented effectively.

• May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.

• May help lead audit readiness for TUV Audits & FDA Inspections. May facilitate Contract Manufacturing Organization’s FDA readiness for Pre-Approval Inspections.

• May facilitate Lab activities for product data generation.

Qualifications :

• Thorough knowledge of applicable procedures, specifications, regulations and standards. Compliance knowledge in the areas of medical device product development, change control, CAPA, and risk management. Knowledge of medical device standards FDA (21 CFR Part 820), ISO 13485, and ISO 14971. Experience/knowledge in other medical industries considered an asset.

• Strong analytical and problem-solving skills utilizing DMAIC tools; Six Sigma Engineering, ASQ or other certifications desirable; general understanding of applied statistical methodologies

• Ability to work with minimal supervision and to make decisions even if provided with limited information

• Good interpersonal/communication/influencing/negotiation skills. Ability to foster cross-functional working relationships in an international environment. Strong written and verbal communication and leadership skills. Ability to mentor junior employees.

• Good project management skills.

• Prior lead auditor experience preferred.

• Demonstrated business acumen; international experience

• guidelines for therapeutics.

• Languages – very good level of English, any other language is an asset

• Basic computer Skills (WORD, Excel, Power Point, MS Project, Minitab, Outlook).

Education:

• BS in science or engineering.

• 8+ years’ experience in Quality, Manufacturing, Engineering or related field.

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.

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