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Director, Quality Puerto Rico (Aibonito, Jayuya and Guyama)

Req #: 170005F8_en
Location: Jayuya, PR US
Job Category: Quality
Date Posted: 10/5/2017 3:17:44 PM
Baxter International

Description

Director, Quality Puerto Rico (Aibonito, Jayuya and Guyama)
Baxter International Inc.
Location: Director will have an office in both Aibonito and Jayuya, 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 Director, Quality Puerto Rico develops and deploys the quality system for Puerto Rico including several plant and laboratory sites including Aibonito, Jayuya and Guyama.  The person in this role assures systems and procedures for regulatory compliance are established and deployed. He/She provides subject matter expertise for regulatory inspections. Acts as a compliance officer for all Puerto Rico facilities, ensuring 100% compliance and top quartile Quality performance and will Interact directly with the San Juan FDA District Office when needed.    

 

Essential Duties and Responsibilities:

  • This position reports to the VP, Quality.
  • Provides subject matter expertise and quality authority for all quality regulated activities within Puerto Rico.
  • Develops and maintains positive relationships with all regulatory bodies (including FDA).
  • Develops and implements continuous improvement initiatives for quality and production within Puerto Rico that may span multiple functions with the objective of improving quality, reliability and cost improvements.
  • Responsible for results in terms of product quality and conformance to regulations and Baxter policies.
  • Ensures the deployment of 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 across multiple plants. Manages regulatory inspections.
  • Reviews the suitability and effectiveness of the quality system and ensures audit readiness plans are implemented.
  • Interacts frequently with all levels of internal management as well as across functions and business units.
  • Manages interactions with customers and regulators concerning the quality of products, systems and processes.
  • Acts as an expert in Quality as a representative for Baxter for internal and external organizations.
  • Standardize practices across plants when needed and benchmark with other Baxter facilities.

     

Qualifications

Qualifications:
  • Recognized expert in Quality by internal stakeholders and external organizations (industry and regulatory).
  • Significant multi-site plant managerial experience.
  • In depth knowledge of the regulatory environment for manufacture of medical products in Puerto Rico.
  • Strong leadership skills and demonstrated success in managing and influencing leaders indirectly.
  • Strong analytical and problem solving skills.
  • Excellent verbal and written communication skills.
  • Excellent interpersonal/communication/influencing/negotiation skills required.

 

 

Education and Experience:  

  • BS in science or engineering; advanced degree preferred. 
  • Minimum of 10 years experience in Quality, Manufacturing or related field in the medical products industry.
  • 7 years 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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