QA Director

**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**:
The **Quality Director**, based on the production site of Meyzieu, will be in charge of implementing, managing and maintaining an effective Quality Management System in compliance with the current ISO 13485 standard requirements. They will certify compliance of the medical devices with the essential requirements of the European Directive 93/42/EEC, MDR (EU) 2017/745 and all other regulatory requirements for countries in which the products are sold.

As well as ensuring commitment in risk management activities & compliance, they will guarantee that only products aligning with their labelling and pre-determined specifications are released on the market.

Reporting to the VP Quality Medical Devices EMEA, they will be part of the site's management team, and the Appointed Person Responsible for Regulatory Compliance (PRRC) for Meyzieu legal manufacturing plant.

**What you'll be doing**:
As leader for the Quality Assurance department, you will have the following responsibilities:

- Sign-off authority for changes to procedures, processes, designs, etc.
- Authority to act on behalf of top management during the audit
- Authority to place products or processes on hold
- Responsibility for managing quality audit functions
- Responsibility for contributing to corrective and preventive action activities, complaint handling, and the handling of nonconforming product, etc.
- Develops and implements appropriate quality indicators within the organization and reports them to Senior Management.
- Establishes, approves and maintains appropriate QS documents and their changes.
- Decides about actions to be taken in case of non-conformity, including remedial and corrective actions.
- Participates to the Local CAPA Review Board.
- Approves internal audit program
- Coordinates the Regulatory audits and inspections.
- Ensure communication (if needed) to competent authorities and notified bodies
- Establish Quality Plan for the plant including Quality Objectives in collaboration with the Plant Manager (MWER)
- Establish and follow the annual budget for the QA Organization.
- Consolidate resource needs and training needs
- Establish and implement a continuous quality improvement program.

**What you'll bring to the role**:
You have significative experience in managing Quality Control activities including knowledge of statistical techniques and sampling plans, in the medical device industry.

Expert in risk management, you are at ease with risk analysis at system, process and product levels and technical investigation's methodology as well as running a CAPA system.

Proven record of successfully dealing with complaint handling, vigilance reporting and driving field corrective actions.

Confident with different audit techniques

Excellent knowledge of:

- ISO 13485 Standard and Canadian Regulations and MDSAP.
- European Directive relating to Medical Devices
- 21 CFR Part 820, 803, 806 and 21 CFR Part 11

**Reasonable Accommodations**

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