**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.
Position Summary: The Quality Systems Manager is responsible to maintain the integrity of quality management system, ensure QMS remains updated and complaint to applicable regulation and standard updates and QMS enables organization to achieve its goals.
Position Responsibilities:
- Ensure the proper functioning and continued effectiveness of Quality System procedures, maintaining compliance with required standards and regulations (e.g.
ISO 13485, ISO 9001, FDA QSR, MDD, Canadian MDR, etc.).
- Acts as primary Subject Matter Expert on Quality Management Systems for Hill-rom.
- Leads development and implementation of improvements to the Quality Management System across the organization, including site integration into Sector and corporate global procedures.
- Provide leadership, direction, and training to Quality System procedures.
- Ensure corrective and preventive action system is effective, also oversees the CAPA program and site CAPA review Board (CRB).
Ensures linkages between site-level CRB and corporate Global CRB.
- Oversee Notified body (GMED) communications and request and ensure timely responses, also provide support to regulatory representatives of Cardiology on matters related to QMS reports for product registrations.
- Develop/compile Management review presentation with inputs of all stakeholders and Coordinate Management Review meeting.
- Primary representative for activities and communications associated with internal, customer and regulatory audits performed at Hill-Rom; ensure resolution of reported non-conformances.
- Maintains the internal audit plan/schedule and coordinates audit activities to ensure company requirements are met.
Acts as Lead Auditor for internal audits.
- Oversees document control process and training assignments related to QMS procedures
- Mentor in quality systems and quality tools for the organization.
- Write, review, and approve quality system documents.
- Assist in preparation of annual budget request.
- Performs other duties as requested.
Required:
- Bachelor of Science degree in engineering, business or a related field.
- At least 8 years relevant experience within the regulated industries.
- Certified Lead Auditor training by notified body or relevant experience.
- Experience with regulatory audits (FDA, ANVISA, etc); Notified Body audits (DQS, GEMD, BSI, etc) and Certification Testing Laboratories (Intertek, UL, etc).
- Proficient in the Microsoft Suite: Excel, Word.
- Training In corrective actions (CAPAs).
Preferred:
- American Society of Quality Certification.
- Fluent in English (both written and oral).
- Ability to read written electrical schematics.
- Excellent written and verbal skills, strong analytical skills.
- Leadership skills and abilities:
- Ability to lead others and get results through others.
- Ability to develop employees beyond their current abilities and manage workload
- Ability to delegate.
- Behavior skills and abilities:
- Proactive, systems thinking approach
- Ability to work under mínimal supervision.
- Ability to work well in groups.
- Ability to work in a fast-paced high stress environment & Calm under pressure.
- Good listening skills.
- Open to new ideas, creative, ability to learn new skills and concepts easily, flexibility and adaptability, good organizational and planning skills, and detail orientated.
**Reasonable Accommodations**
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