Full-Time

Quality Manager

Posted on 1/18/2025

Baxter International

Baxter International

10,001+ employees

Provides essential medical products and services

Biotechnology
Healthcare

Compensation Overview

$104k - $143kAnnually

+ Discretionary Bonuses

Senior, Expert

No H1B Sponsorship

Burnsville, NC, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • 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.
Responsibilities
  • 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.
Desired Qualifications
  • 5+ years of management experience preferred
  • Past experience as an FDA Inspector preferred
  • Independent Certifications desired (e.g. CQA, ASQ, RAPS)

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals globally. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Company Stage

IPO

Total Funding

N/A

Headquarters

Deerfield, Illinois

Founded

1931

Simplify Jobs

Simplify's Take

What believers are saying

  • Baxter's investment in Medically Home aligns with the growing home healthcare market.
  • Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.
  • Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

What critics are saying

  • Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.
  • Shift to home healthcare may require Baxter to adapt its product offerings.
  • Growing digital health importance necessitates further investment from Baxter to stay competitive.

What makes Baxter International unique

  • Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.
  • Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.
  • Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

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Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support