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Quality Engineer (Sterilization)

Medtronic


Location:
Singapore
Date:
05-01-2021
2021-01-052021-02-12
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Job Details

Quality Engineer (Sterilization)

Location:

Singapore, Singapore, Singapore

Requisition #:

20000LFB

Post Date:

Jan 03, 2021


**Careers That Change Lives**


**Medtronic Singapore Operations** was among the **first international medical technology firms** to set up manufacturing operations in Singapore. We are one of the **most advanced** medical device manufacturing sites and the first manufacturing facility of its kind in the region to make **implantable cardiac leads, pacemakers and monitors.**


**Our Purpose**


Founded in 1949, our **Mission** continues to serve as our ethical framework and inspirational goal for our employees around the world. It guides our day-to-day work and reminds us that; our efforts are **transforming the lives** of millions of people each year.If you have a passion for medical device manufacturing, this opportunity could be for you!


Medtronic is intensely focused on creating a workplace environment which reflects our standing as the **worlds top medical device company** . We are looking for talents to join our award-winning teams - **Medtronic Global Quality Award winner, Star of Excellence Award winner for Quality Innovation** **and** **2 times recipient of Best Plant Award-Cardiovascular Group** .The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business.


**A Day in the Life**


As a **Quality Engineer** , you are responsible to assure that **sterilization and Microbial Monitoring** comply with the specification and regulatory government agencies requirements. You will participate on internal, interfacility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements. On top of that, you lead /participate in the improvement projects for sterilization, Microbial Monitoring process.


Responsibilities may include the following and other duties may be assigned.


+ Assure that processes comply with specifications, Quality Systems Regulations and ISO standards. Ensures compliance to FDA, PMDAregulationsand ISO13485.

+ Work with Engineering, Manufacturing and Facilities team to ensure sterilization and Microbial Monitoring meet specification and requirement. Establish a mechanism to evaluate, measure, and/or monitor the performance of these processes and implement corrective / preventive actions.

+ Provide support on validation and qualification related to processes at sterilization and Microbial Monitoring.

+ Provides support to production for any technical issue and other activities (Nonconformity management, training, maintenance, etc.).

+ Apply statistical tools in order to assure that processes comply with the specifications.

+ Collaborate, update and maintain all FMEA on sterilization and Microbial Monitoring.

+ Product quality engineering support to below areas:


+ Microbiology Bioburden data, Endotoxin data, Environmental Monitoring data

+ Sterilization Routine Release

+ Document updates related to Microbiology and Sterilization

+ Out of Specification data and Corrective / Preventive Action related to Microbiology and Sterilization.


+ Leads/Participates the maintenance of sterilization equipment and process/ equipment related improvement.

+ Work on projects assigned by Supervisor/Manager.


**Must Have: Minimum Requirements**


+ Bachelors Degree in engineering or Science (Microbiology, Biotechnology, etc).

+ Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience


**Nice to Have**


+ 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

+ Preferably experience in the cleanroom and/or CEA Monitoring


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


Physical Job Requirements


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.


The physical demands described within the Day in the Life section of this job description 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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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