16 days old

Change Configuration Specialist

Singapore, SG-01
  • Job Code

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

Written in 1960, 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 world's 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 Change Configuration Specialist, you are responsible to ensure the compliance of quality system towards applicable medical devices regulations such as but not limited to ISO13485, QSR (FDA), Chinese Regulations or Japanese Regulations. The compliance encompasses also the business unit and corporate requirements. You serve as the organizational focal point for Change Control, document & records control processes to maintain the Quality Documentation through the use of documentation control system.

Key Accountabilities

  • Ensure that all QMS change are properly captured, reviewed, deployed and documented and be the Change Analyst process / administer changes and support implementation of change control processes
  • Ensures requirements are implemented and reviews change to ensure compliance with configuration management procedure.
  • Review /Analyzes proposed changes to determine effect on Quality Systems, manufacturing processes
  • Work with Change Owners on Document and Records Controls process change implementation and ensure changes are track accordingly.
  • Support the training on new hires and MSO employee on quality related topics. Create, update and develop the training material as assigned
  • Works and implements special improvement assignment/projects as assigned by Direct Supervisor.

Must Have: Minimum Requirements

  • Bachelor's Degree in any discipline and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Your Profile
  • Experience working in medical device, pharmaceutical or related industry will be preferred
  • Familiar with Quality System Regulation and knowledge of Quality System Regulations and ISO.
  • Effective interpersonal, communication and influencing skills
  • Relevant experience in manufacturing work environment

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. Let's 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.

Additional Information

  • Posting Date: Jan 3, 2021
  • Travel: No

Posted: 2021-01-05 Expires: 2021-02-03
Sponsored by:
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Change Configuration Specialist

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