Sterilization Engineer
2 weeks ago
Careers that Change Lives
Engineers are indispensable to achieving our Mission. That's why we empower you to bring the best of your experience to bear on our market-leading portfolio of innovations. Apply your existing skills and develop new ones, with the training, mentorship and the guidance you need to continue to develop your expertise. With roles in specific business units, as well as at the corporate level, you're sure to find an opportunity to make an impact that's right for you.
Today, we're partnering across the industry to confront systemic healthcare challenges - this requires bold leadership. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.
A Day in the Life
The Quality Engineer be responsible to ensure that sterilization process comply with the specification and regulatory government agencies requirements - FDA, PMDA, ISO 13485. Will lead and participate in the Global Sterilization committee and standardization.
- Lead/participate sterilization process meets specification/requirement, maintenance of sterilization equipment, process and equipment improvement
- Provide support to production for any technical issue and other activities (Nonconformity management, CAPA, training, calibration, maintenance, etc.).
- Collaborate, update and maintain FMEA for sterilization.
- Support, review and approve the following processes:
- Document updates/approvals related to Sterilization
- Routine Sterilization Release
- Corrective / Preventive Actions related to Sterilization
- Work on special projects assigned by Supervisor/Manager.
Must Haves:
- Bachelor's degree in engineering (Biomedical engineering, biotechnology, etc.) or equivalent.
- Minimum 2 years' experience in engineering role related to manufacturing of medical devices.
Nice to Have:
- Good communication and interpersonal skills, ability to articulate ideas clearly and concisely to people of all levels.
- Preferably experience in EO Sterilization, sterilizer equipment, and/or Bioburden / Endotoxin testing
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