北京招聘

Corporate Job Title: Quality Engineer

Local Business Title: Quality Engineer

Location: Singapore

Main Purpose:

• Responsible to assure that sterilization process comply with the specification and regulatory government agencies requirements (FDA, PMDA, ISO 13485, etc.).

• Responsible to assure that sterilization are validated and qualified according to schedule.

• Leads and participates in the Global Sterilization committee and standardization.

Key Accountabilities:

• Assure that sterilization process comply with specifications, Quality Systems Regulations and ISO standards. Ensure compliance to FDA, PMDA regulations and ISO 13485.

• Lead/Participate sterilization equipment/process qualification.

• Align sterilization process by working with the global team for global process development and qualification protocol and execution.

• Ensure sterilization process meet specification and requirement.

• Lead/Participate the maintenance of sterilization equipment.

• Provide support to production for any technical issue and other activities (Nonconformity management, CAPA, training, calibration, maintenance, etc.).

• Lead/Participate the process/ equipment improvement.

• 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.

Attributes:

• Promote an ethical behavior.

• Flexibility and adaptability

• Team work

• Detail oriented

• Provide engineering counseling to less experienced engineers.

• Patience and perseverance

Experience and Knowledge:

• Minimum 2 years’ experience in Bio-Medical Engineering related to manufacturing of medical devices, preferably in quality assurance.

• Good communication and interpersonal skills, ability to articulate ideas clearly and concisely to people of all levels.

• Preferably experience in EO Sterilization, and/or Bioburden / Endotoxin testing

Qualifications:

• Bachelor Degree in Engineering (Microbiology, Biotechnology, etc.) or equivalent

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.