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Mgr II, Quality

Req #: 170006GB_en
Location: Irvine, CA US
Job Category: Quality
Date Posted: 11/1/2017 3:44:25 PM
Baxter International

Baxter International Inc. 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; biosurgery 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 50,000 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.

 

Leads a team of Quality professionals to develop, implement and sustain plant quality Engineering practices with Baxter and Regulatory Quality system requirements. Serve as thought leader, subject matter expert and coach on a broad array of quality system elements, including but not limited to Process Controls, Qualification & Validation, Risk Management, Corrective and Preventive Actions. Manage through subordinates the coordination of the activities of several sections or departments in the Quality organization. Responsible for results in terms of product quality and conformance to regulations and Baxter quality policies
Assigns and manages the work of self and direct reports to:
Develop and implement systems, procedures and policies to assure compliance with appropriate regulatory agencies and regulations to include but not limited to ISO Standards, cGMP's, FDA regulations and company policies and procedures.
Author, review and implement the quality systems procedures in several sections or departments and manages compliance to the system.
Drives quality and manufacturing improvements to ensure our processes are in state of control.
Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes.
Manage interactions with regulators and customers to represent the company products and processes.
Develop and analyze statistical data and product specifications to determine present standards and establish proposed finished product’s quality and reliability expectancy.
Apply standard operating practices and problem solving methodology across the organization. Serve as role model and coach to employees at all levels in the application of best practices.
Identify and lead projects and initiatives to improve the quality system. Interact with Baxter larger organization on projects and initiatives as assigned. 
Manage and develop staff.
Financial responsibilities and accountabilities include: department and capital budgeting and expenditures for areas of responsibility.
Understands and assures conformance to regulations applicable to several sections or departments. Interfaces with regulators during inspections.
May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
Excellent command of process validation and risk management for medical device.
Thorough knowledge of applicable procedures, specifications, regulations and standards.  
Demonstrated Experience managing quality personnel, specifically Quality Engineers, managing performance and developing teams. 
Demonstrated ability to work cross functionally and interact with plant and corporate personnel at all levels.
Engineering depth and ability to understand product and process operating principles, control points and methods, design and process interactions and end user impact.
Demonstrated capacity to develop validation strategy and lead team to execute. 

BS in science or engineering; advanced degree helpful.
7 years of experience in Quality, Manufacturing, Engineering or related field.
4 years of management experience.
The physical activity of this position
  • Fingering. Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
  • Talking. Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly
  • Hearing. Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound
  • Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers – as related to administrative work.
The physical requirements of this position
  • Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
 
The visual acuity requirements including color, depth perception, and field vision
  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes
 
The conditions the worker will be subject to in this position
  • None. The worker is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work.)

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