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Associate Director Quality

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Saint Paul

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

160000.00 - 220000.00 USD / Year
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Job Description:

This position is responsible for being Most Senior plant level Quality Management Representative, developing and deploying the quality system for the plant, assuring systems and procedures for regulatory compliance are established and deployed.

Job Responsibility:

  • Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
  • Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
  • Ensuring Post-Market Surveillance (PMS) obligations are met
  • Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
  • Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
  • Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
  • Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
  • Periodically reviews the suitability and effectiveness of the quality system with executive management
  • Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
  • Assesses and advises senior management concerning acquisition targets
  • Interacts frequently with all levels of internal management as well as across functions and franchises
  • Manages interactions with customers and regulators concerning the quality of products, systems and processes
  • Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility
  • Develop budget for quality organization Department and ensures adherence to the budget
  • Manages overall coaching, training, development and succession plans for the team

Requirements:

  • In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
  • Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
  • Strong analytical, problem solving, and decision-making skills
  • Excellent verbal and written communication skills
  • Success working with multifunctional, global teams
  • Excellent interpersonal/communication/influencing/negotiation skills required
  • Extensive working knowledge of applicable quality and regulatory standards and regulations
  • Experience in risk management, validation, analytics and microbiology, within a GMP environment
  • Quality expertise on tech transfer
  • Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment
  • BS in science or engineering
  • advanced degree helpful
  • Minimum of 10 years of experience in Quality, Manufacturing or related field in the medical products industry
  • 7 years management experience
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • educational assistance programs
  • paid holidays
  • paid time off ranging from 20 to 35 days based on length of service
  • family and medical leaves of absence
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits

Additional Information:

Job Posted:
April 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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