Sr. Eng. Quality Systems
hace 3 semanas
**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.
**JOB SUMMARY**:
- Proactively review, analyze and implement opportunities for continual improvement of the Global QMS to meet business needs.
- Establish and maintain metrics and feedback mechanisms to monitor continued effectiveness of the systems to business and regulatory needs.
- Quality systems
- Complaints Process
- Training Process
- Often must lead a cooperative effort among members of a project team.
- Support external quality and regulatory agencies for audits
- Define the strategy for Audit readiness for the site,
- Coordinates CAPA/NCR´s process for the site
- Manage CAPA process
- Assist as needed with corporate with Quality Systems initiatives
- Define and coordinate Training requirements for the site
- Assure the training is provided effectively on new and actual employees of the site
- Manage the Quality Management System.
- Define and train internal auditors
- Manage the logistics quality system through a third party.
- Maintain and improve document system
**EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS**:
- B.S. Degree in Engineering or technical degree.. B.S. Degree in Engineering or technical degree.
**Desirable experience**:
- Education or training in quality control techniques including quality system auditing, statistical process control, design of experiments, regression analysis, and statistical sampling methods.
- Three years of experience in manufacturing operation as quality or manufacturing engineer.
- Experience in medical device regulations and standards, including FDA medical device regulations covered under Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC.
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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