Job Function Summary:
The Quality Engineer provides support to the Sterilization and Controlled Environment Team related to change control, and continuous improvement initiatives and facilitates product and environmental monitoring testing. The Quality Engineer also performs tasks, related to process validations, nonconformance review, SOP development and other compliance activities related to the Sterilization and Environment Control programs.
- Support and execute change control activities in Agile (document management system) related to sterilization and environmental control programs including procedure updates, quality plans, risk management files and regulatory standard assessments.
- Support environmental and product microbiological testing programs by collecting samples, facilitating testing with contract testing services, maintenance of databases and trending programs.
- Support the execution of sterilization qualifications, EO residual testing and microbiological testing including analyzing and trending of data using statistical tools. Prepare validation test reports.
- A Bachelor`s Degree preferably in a scientific discipline; biology, chemistry or engineering.
- 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.
- Minimum of 1 to 2 years experience working in the medical device or pharmaceutical industry. Understanding of regulatory standards 21 CFR, ISO 13485.
- Experience with sterilization and microbiology programs is a plus.
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.
We look forward to receiving your application.
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