Sterility Assurance Engineer I


MICROPORT ORTHOPEDICS
MICROPORT ORTHOPEDICS 5677 AIRLINE ROAD
Arlington, TN 38002-9501
United States

Category
Industry
Manufacturing
Manages Others
No
Experience Required
Yes
Degree Required
Yes
Security Clearance Required
No
Employment Type
PartTime/Full Time
Work Schedule
Full-Time
Travel
Some Travel

Job Description
Overall Purpose

The Sterility Assurance Engineer I is responsible for supporting the terminal sterilization [Ethylene Oxide (EO), Gamma Radiation and Steam/Reusable Instruments] of medical devices in a global regulatory environment. The position will support Sterility Assurance and Manufacturing.

Principal Responsibilities

The Sterility Assurance Engineer I will be responsible for the following activities:

  1. Review and release of sterilization loads, which includes, but not limited to, the review of biological indicator test results.
  2. Supporting the validation/ revalidation/ requalification of all MicroPort Orthopedics' sterilization methods (i.e. EO, Gamma and Steam/Reusable Instruments) and Environmentally Controlled Areas.
  3. Supporting the Environmental Monitoring and Sterility Assurance Testing Programs.
  4. Conducting contract sterilization vendor and laboratory audits, as required.
  5. Supporting special projects, as necessary.
  6. Performing other assigned tasks in support of the department, as needed.
This is a high-level, decision-making, and professional position in a technical environment. It requires an advanced ability in problem solving, analysis, reasoning, and creativity in order to perform the duties expected.


Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Job Requirements
Skills Requirements

Required: 

 Cleanrooms/ Environmentally Controlled Areas (ECA) and contamination control experience. The candidate must exhibit an above average knowledge of cleanroom/ ECA and contamination control concepts and requirements (i.e. ISO 14644 and ISO 14698). 
 Sterility Assurance testing (i.e. Bioburden testing, Sterility testing, Endotoxin testing, EO residual testing, etc) experience. The candidate must exhibit an average knowledge of Sterility Assurance testing concepts and requirements (i.e. ANSI/ AAMI/ ISO 11737, ANSI/AAMI ST72, ANSI/AAMI/ ISO 10993, etc.) 
 Knowledge of medical device regulations (i.e. 21 CFR Part 820 and ISO 13485).
 Technical writing experience (i.e procedures, protocols, final reports, sterilization equivalency, etc).
 The candidate must display excellent leadership, communication, and interpersonal skills. In addition, the candidate must be able to work on cross-functional teams, as well as independently (i.e. little to no supervision).

 Preferred: 

 Ethylene oxide and/or gamma sterilization experience. The candidate must exhibit an average knowledge of ethylene oxide and/or gamma sterilization concepts and requirements (i.e. ISO 11135 and ISO 11137).
 Steam/Reusable Instruments sterilization experience. The candidate should exhibit knowledge of the reusable instrument sterilization requirements.
 Knowledge of packaging and product design issues as they relate to sterilization.
 Knowledge of calibration requirements.
Accountability

This position is accountable for supporting the terminal sterilization of medical devices globally.  Failure to maintain accountability for MicroPort Orthopedics sterilization program may result in sever physical harm to a patient’s well-being, in addition to having severe financial and regulatory repercussion to MicroPort.

Experience Requirements

1-3 years of related experience

Education Requirements

Bachelor’s Degree in Life Sciences, Engineering or a related discipline required
Employer
MICROPORT ORTHOPEDICS
Maggie Day
MICROPORT ORTHOPEDICS 5677 AIRLINE ROAD
Arlington TN 38002-9501
United States
MICROPORT ORTHOPEDICS Maggie Day