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Engineer I, Quality Sterilization

Glens Falls, NY, USA ● Queensbury, NY, USA Req #35
Tuesday, February 2, 2021

JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE 

It takes a team of talented people to become one of the world’s leading providers of innovative medical devices.   
 

AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.


We accomplish this through: 

  • A Commitment to the Highest Standards of Quality 
  • Relentless Innovation 
  • Operational Excellence 

Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry.  
 

We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

JOB SUMMARY To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 

Supports sterilization, environmental and product monitoring programs.  Plans and directs activities concerned with design, development, application, validation, implementation and maintenance of quality standards to ensure new and existing products meet requirements for sterilization, microbiology and biological safety.

Essential Duties and Responsibilities

  • Sterilization Cycle Validations:
    • Assists in the planning and maintenance of cycle/process validations in approved or proposed sterilizer equipment
  • Product Adoptions:
    • Responsible for planning, writing, and advising on Sterilization Evaluations and Qualifications for new or changed products.  
  • Sterilization Routine Processing:
    • Support day to day sterilization opertations including process document review, contractor and laboratory communications, mitigation of process deviations.
  • Biological Safety:
    • Responsible for planning and writing Biocompatibility Assessments and Reports to evaluate new or changed products.
  • Product Monitoring:
    • Assists in scope, planning, and maintenance of Product Bioburden and Bacterial Endotoxin monitoring programs.
  • Environmental Monitoring:
    • Assists in scope, planning and maintenance of Environmental monitoring programs.
  • Serves as a plant resource for:
    • Consultant in interpretation of ISO/FDA/AAMI regulations related to sterilization, environmental monitoring, and/or biological safety.
    • Procedure generation/modification.
  • May perform other duties as assigned

Supervisory Responsibilities

No

Regulatory Responsibilities

  • Manages in order to ensure compliance with all relevant regulatory/legal requirements

 

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

Management

Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure all employees are trained to do their work and their training is documented

QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill or ability required.

Education and Experience

  • Bachelor's Level of Degree in the Biological Sciences or Engineering field of study
  • Equivalent work related experience acceptable in lieu of degree: No
  • 0-3 years of demonstrated experience in scientific discipline with an emphasis on chemistry, microbiology, biology, or biomedical sciences.
  • No Certifications Required
  • Any preferred education, experience or certifications:  Knowledge of biocompatibility of materials preferred

Skills/Knowledge

  • Familiarity with regulations and standards published by FDA, USP, HIMA, AAMI, ANSI, ASTM, and ISO.
  • Knowledge of probability and statistics, experimental design methods.
  • Technical writing and oral communication skills.
  • Working knowledge of computers, spreadsheets, databases, and statistical programs.
  • Proficient in the following computer software applications: Microsoft Office
  • Exceptional interpersonal skills.
  • Strong organizational skills.
  • Strong communication skills (written and verbal).
  • Ability to effectively communicate both internally and externally.
  • Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.

PHYSICAL/WORK REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

  • Work safely and follow all OSHA regulations and company safety policies and procedures.
  • For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
  • Exposure to (insert any extreme climate and/or work conditions)  standard office environment
  • Ability to frequently lift and/or move up to 15 lbs.
  • Ability to occasionally lift and/or move up to 50 lbs.
  • Ability to regularly sit or stand for extended periods of time .
  • This position requires some travel up to 10% of the time
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status.

The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. 

AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.
 

Other details

  • Job Family 2.1 Technical Professionals
  • Job Function Quality
  • Pay Type Salary
This posting is inactive.
  • Glens Falls, NY, USA
  • Queensbury, NY, USA