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Quality Engineer Sterilization Controlled Environment - Merrimack, NH

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Date: Jul 17, 2021

Location: Merrimack, NH, US

Company: Getinge

Job Function Summary:

 

 

The Quality Engineer will provide subject matter expertise to the Sterilization and Controlled Environment Team in support of functions critical to the safety of Class II & III medical devices. The role is responsible for supporting the validation of new and existing sterilization modalities, fostering improvements to legacy processes, and using critical thinking and analytical reasoning to investigate environmental non-conformances.  This includes support for change control activities, and continuous improvement initiatives and facilitating product and environmental monitoring testing.

 

Who You Are:

 

 

Someone with a strong background in microbiology or sterilization and experience demonstrating compliance for medical devices and components. This may include experience in microbiological test method validation, cleanroom monitoring, ethylene oxide/gamma sterilization, and change management coordination.  You have both hands on experience in testing medical devices or the cleanrooms they are manufactured in as well as strong analytical, interpersonal, and protocol/ report generation skills. You possess the ability to thrive in a fast-paced, multidisciplinary environment supporting the team effort to drive product completion and strive to play an active role in company objectives as well as your own personal growth and development.    

 

Job Functions:

 

 

  • Support environmental and product microbiological testing programs by facilitating testing with contract testing services, collecting samples, and maintaining of databases and trending programs.    
  • Support the execution of EO sterilization qualifications, annual reviews, and radiation dose audits. Interface with contract sterilizer and contract lab suppliers.
  • Review microbiological testing data including analyzing and trending using statistical tools.   
  • Compile validation reports for clean room qualification and sterilization validations.
  • Support and execute change control activities in Agile (document management system) related to sterilization and environmental control programs.  Author or revise procedure updates, quality plans, risk management documentation, and regulatory standard assessments.
  •  Provide support for controlled environment and sterilization Nonconformance or excursion events including root cause investigation.  
  • Support product enhancement projects and new product introductions. 
  • Provide a technical resource for training site personnel for gowning and microbiological control programs.
 

Minimum Requirements:  

  • A Bachelor`s Degree preferably in a scientific discipline.
  • Minimum of 2 years experiences working in the medical device or pharmaceutical industry. 
  • Understanding of regulatory standards 21 CFR, ISO 13485, 14644-1, 11135-1.
  • Experience with sterilization and microbiology programs.
  • Strong skills using Microsoft Office products such as Outlook, Word, Excel and Power Point.
  • Experience with statistical software, SPC process control and ability to analyze data and interpret result
  • Experience using Quality System Software tools, such as Agile.
  • Experience working with ISO 5 class room environments is a plus.

 

Quality Requirements:

  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
  • Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
  • Attend all required Quality & Compliance training at the specified interval.
  • Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

  • Able to work in a controlled clean environment as required.
  • May have to lift up to 20 lbs.
  • Personal protective equipment may be required as dictated by the clean room work environment.

 

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

 

 

 

 

 

 

 

Thank you for your application.  


Nearest Major Market: Manchester
Nearest Secondary Market: Nashua