Quality Manager, I (6:45am-2:45pm)

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role at Baxter

This is where your creativity addresses challenges

Lead, both individually and through subordinates, the coordination of all activities of the Quality Compliance team. Responsible for results in terms of compliance, product quality and conformance to regulations and Baxter quality policies.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What we offer from Day One

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

What you'll be doing

• Manage the activities of the Regulatory Intelligence department in the Quality organization with responsibility for results in terms of compliance, product quality, performance, and safety.
• Plans for, implements, and follows up on audits and FDA inspections.
• Understands and assures conformance to regulations. Works with regulators during regulatory inspections.
• Implements and improves the quality systems procedures related to site regulatory compliance.
• Participate in or run quality assessments of internal operations and suppliers to analyze compliance and assess risk.
• Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Interacts frequently with subordinate supervisors and functional peer group managers.
• Develops budget for the compliance team, and ensures adherence to the budget.
• Manages, Coach, engage, train and develop direct reports.

What you'll bring

• Bachelor’s degree (Science or Engineering preferred)
• 10+ years’ demonstrated experience in Quality, Compliance, Manufacturing, Engineering, or related field
• 5+ years of management experience preferred.
• Past experience as an FDA Inspector preferred.
• Independent Certifications desired (e.g. CQA, ASQ, RAPS).
• Thorough knowledge of applicable procedures, specifications, regulations (CFR Parts 210, 211, and 820) and standards.
• Subject Matter Expert in current Good Manufacturing Practices (cGMP) and auditing
• Strong technical, analytical, judgment and problem-solving skills.
• Ability to lead/supervise a team of employees.
• Ability to build relationships across functional boundaries at multiple levels internally / externally.
• Excellent verbal and written communication skills, including presentation skills.
• Strong courage of conviction, conflict resolution, interpersonal and influencing skills.
• Demonstrate multitasking, project management, and execution skills.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may a