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Quality Engineer more...
Location:Cary, IL
Company:Stryker
First posted:January 19, 2017
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About Stryker:
Stryker is one of the world's leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

On April 1st 2016, Sage Products became a part of the Stryker family. Founded in 1971 and headquartered in Cary, IL, Sage is a leading developer of innovative products and proprietary solutions that are designed to help improve outcomes for patients and clinicians, while maximizing efficiency and profitability for healthcare facilities. Sage's products include solutions for oral care, skin preparation and protection, patient cleaning and hygiene, turning and positioning devices and heel care. Sage's 45-year focus on patients and caregivers is evident in the company culture. Sage is well-positioned for continued long-term success with Stryker, a company that shares the same values and goals.

Job Description / Information:
The Quality Engineer will conduct quality investigations including root cause identification of nonconformance.   The Quality Engineer will participate in the performance of routine quality system functions. In addition, the Quality Engineer will participate in development and implementation of continuous improvement projects.
 
The Quality Engineer will be responsible for, but not limited to the following:

  • Collect, analyze and summarize data to identify cause analysis to provide in depth descriptions of manufacturing anomalies
  • Compose detailed, methodical descriptions of deviations and nonconformance through investigative writing 
  • Create and explain data analysis through graphs, charts and pivot tables as needed
  • Communicate problems clearly to staff and team members of different technological backgrounds
  • Maintain a vast workload with the ability to prioritize based on business needs
  • Provide quality related support to all areas of the plant as necessary
  • Provide guidance on quality related issues as they arise
  • Track investigations within the  nonconformance and/or customer complaints workflow to identify trends
  • Author and/or revise Standard Operating Procedures as required
  • Read and understand descriptions, communications, reports, tables, diagrams, directions, regulations, etc.
  • Participate in Quality auditing as part of the Sage Quality System
  • Identify and or participate in continuous improvement processes
  • Maintain a knowledge base that is consistent with FDA regulations

Minimum Qualifications:
POSITION REQUIREMENTS

  • A Bachelor's degree in Engineering, Science or a related field is required.
  • Three (3) years of work experience.
  • Experience in a cGMP regulated pharmaceutical or medical device environment required (specifically 21CFR211 and 21CFR820).
  • Computer literate in Microsoft Word, Excel and Outlook.

ENVIRONMENTAL CONDITIONS

  • The Quality Engineer is subject to controlled indoor conditions with some temperature change from occasional tasks outdoors or in the warehouse.  May be subject to short-term exposure to some hazardous chemicals and reagents.
  • Physical Activities include standing, walking, sitting, lifting, carrying, reaching, handling, talking, hearing, pulling, pushing, grasping.
  • Must be capable of accurately discerning instrument/equipment displays.  Good color discrimination. 

 
 
 
POSITION COMPETENCIES

  • Excellent interpersonal skills, including the ability to work positively and constructively in a team environment
  • Excellent verbal and written communication skills
  • High level of creativity and flexibility
  • Self-motivated with exceptional follow-through

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