QA Compliance and Audit Manager

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

This is a great opportunity to join a team with a true passion for saving and sustaining lives.

You'll be responsible for overall quality management system implementation in an effective and compliant way with the requirement from regulatory authorities and for the planning and execution of the internal audit program.

You will work closely with local/global QA senior management and peers within Medolla site to Support and deploy the Global QA strategy, being part of the QA Management Team.

Essential Duties and Responsibilities

• Support local SMEs in the impact analysis of global QMS requirements to secure regulatory compliance of the Site QMS

• Performs impact assessment of global QMS requirements to secure regulatory compliance in the Auditing and QMS management area

• Management of Notified Body Quality Certificates in the Site

• Act as Qualified Trainer for QMS requirements from applicable Standards and Regulations (e.g. ISO 13485, FDA QSR, GMPs, Eudralex, EU MMD, EU MDR, MDSAP, etc...)

• Prepare Yearly Internal Audit Planning and manage the execution of local Internal Audit Program

• Act as Inspection Coordinator or support Inspection Coordinator in external audits and inspection from Notified Body, Country Health Organizations and Regulatory Organizations.

• Manage EMS Quality section for Medolla Site and is active in proposing and implementing improvements in all Quality Systems aspects of the site

• Manage the preparation of documents relating to Medolla site for regulatory registrations in the various countries where products are distributed

• Support QMR in keeping compliance list updates

• Perform all budgetary activities in accordance to QA compliance budget area

Qualifications

• University degree in technical matter (better is in engineering field)

• Minimum 8 years relevant experience in QMS Medical Device and/or GMP industry

• Hands on experience in the preparation of quality documents for regulatory agencies and ministry of health

• Knowledge in relevant Quality Regulations and Standards

• Auditor training

• Knowledge of all the corporate functions (supply chain, R&D, manufacturing, purchasing, logistics, technical service...)

• Knowledge of business relations in a global environment

• Knowledge of dialysis treatments, dialysis systems and associated defects is preferred

• Strong passion for all QA's aspects

• Strong communication and negotiation skills

• Excellent knowledge of English

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.