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Medtronic Senior Quality Engineer in Singapore, Singapore

Senior Quality Engineer

Location:

Singapore, Singapore, Singapore

Requisition #:

21000FLZ

Post Date:

Jun 10, 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!

Senior Quality Engineer

A Day in the Life

Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements. Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products. Participate on internal, inter-facility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.

Key Responsibilities:

  • Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.

  • Evaluate product/material discrepancies. (PRB/MRB) on time, and implement corrective actions accordant.

  • Establish mechanism to evaluate, measure, monitor and/or quality in our products.

  • Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers through evaluation/approval of Engineering change request/orders. Ensure update of manufacturing processes in order to reflect quality concepts and specification requirements.

  • Support other Quality Engineer improvement and quality activities as needed.

  • May provide guidance and assistance to less experienced engineer (eg. Quality Engineer I)

  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

  • Ensure that processes comply, with a high confidence level, the tolerances stated on the product specification and drawings.

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

  • Conduct failure investigations in order to initiate, stimulate, and assign corrective action. Issue written reports and update, accordingly.

  • Review and analyze quality trends with the manufacturing team. Analyze data based on trends, recommend actions for process, equipment and system improvement.

  • Work on product transfers activities and actively participate in product qualifications and validations of equipment and processes.

  • Perform risk assessment activities with reliability for product quality risks.

  • Work on special projects assigned by Supervisor/Manager.

Must Have: Minimum Requirements

  • Bachelors degree required

  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

  • Minimum of 4 years of relevant experience related to manufacturing of small electro/mechanical devices, preferably in a quality assurance or test-related capacity.

  • Understanding of Statistical Process Controls is an added advantage

  • Proficient in use of Minitab software is preferred.

  • Knowledge of ISO13485 and FDA requirements (21CFR Part820) is preferred.

  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

  • May have practical knowledge of project management.

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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