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Director, Quality - QMR

Req #: 170007PP_en
Location: Aibonito, PR US
Job Category: Quality
Date Posted: 10/5/2017 3:19:50 PM
Baxter International

Description

Director, Quality - QMR

Baxter International Inc.

Aibonito, Puerto Rico

 

About Baxter 

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services.

 

The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

 

Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

 

Position Overview
The QMR will understand, implement, maintain, and continually improve the effectiveness of the Baxter Quality Management System for the plant.  This role assures systems, processes, and procedures for regulatory compliance are established and deployed. The QMR will ensure compliance to applicable standards and regulations and will manage regulatory inspections.  This position serves as the Management Representative for the plant. The QMR ensures that measurable quality objectives and goals are established and communicated. The other responsibility of the QMR is to directly and through subordinates develop and manage the planning, staffing, training and budgeting for the quality organization. The QMR will manage the Quality organization and direct the quality department in support of the plant, division, and company-wide strategy and initiatives. 
 
Essential Duties and Responsibilities:
  • Ensuring quality and regulatory compliance.
  • Managing regulatory inspection.
  • Developing and deploying the quality systems. Ensuring the quality system processes are effectively established and maintained in accordance with applicable regulations, standards and Baxter Quality System requirements.
  • Reviewing and assessing the suitability and effectiveness of the quality system.
  • Trending and performing data analysis.
  • Coaching, training and developing the quality team.
  • Responsible for the outgoing, safety, quality and efficacy of all finished products manufactured at the plant.
  • Responsible for total compliance with all applicable corporate policies and procedures, corporate and divisional specifications, local standard operating procedures, 510K requirements and all other applicable regulatory requirements.
  • Responsible for total compliance to applicable local, state, federal and international regulations, good manufacturing practices, good laboratory practices and all applicable corporate, divisional, and internal policies and procedures.
  • Responsible for assuring compliance with ISO Standards and all other regulatory standards and requirements.
  • Responsible for the review of the quality system for suitability and effectiveness.
  • Responsible for the development and implementation of all quality system.
  • Responsible for the development and implementation of all quality system requirements and is the Site Management Representative.
  • Responsible for understanding customer needs and requirements.
  • Responsible for adherence to specifications and procedures.
  • Responsible for driving innovation.
  • Responsible for establishing and maintaining an environment that encourages teamwork and collaboration.
  • Responsible for operation excellence and benchmarking, learning and sharing knowledge.
  • Financial responsibilities include total quality department overhead spending and capital budgeting and expenditures.
  • Responsible for developing talent of the team members.

 

 

Qualifications

Qualifications:
  • Strong leadership skills.
  • Strong analytical and problem solving skills.
  • Excellent verbal and written communication skills.
  • Must be able to manage multiple projects and tasks.
  • Must be able to work with minimum supervision.
 
 
Education and Experience:
  • BS in science or engineering; advanced degree helpful.
  • Minimum of 10 years of experience in Quality, Manufacturing or related fields in the medical products industry.
  • 7 years of management experience.

 

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.

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