Singapore, ROBINSON 77, 068896
Parttime: 0 hrs a week
Experience: 1 year
Closing: 05 December 2024

Introduction

What are you going to do 

Our client is a well established medical devices company with a strong product portfolio.

  • Work with cross-functional teams to ensure implementation and/or maintenance of QMS that are appropriate for Medical Devices / Life Sciences Manufacturing / Medical Devices
  • Distribution and Services, complies with Commercial/Distribution Quality System such as GDPMD and may also include, but not limited to FDA 21 CFR Part 820, ISO 9001, ISO13485 and other applicable regulatory and statutory requirements.
  • Support external audit by certification body and/or regulatory inspections by regulatory agencies e.g. US FDA.
  • Coordinate, plan and perform internal audits of processes, facilities and documentation to assure compliance with internal procedures, FDA 21 CFR Part 820, ISO 9001, ISO 13485 and GDPMD regulations and requirements.
  • Establish, maintain and update relevant QMS documentation.
  • Support in the preparation of generation of metrics and reports to support Quality Management Review.
  • Maintain calibration records for all manufacturing tools and equipment.
  • LMS administrative role for local procedure and practice.
  • Interface with production, process, and test engineering to ensure that products are consistently produced and controlled as per ISO / Part 820 requirements
  • Provide QA support in the design, development, sustaining and production of life science / medical device products, facilitating the application of change controls, inspection and testing, risk management activities and quality plan for new product introductions / existing products are in order to sustain product competitiveness while maintaining compliance to domestic and international regulations and standards.
  • Conduct customer feedback/complaints and trend review, and drive appropriate continual improvement implementation

What you should do now

Apply to this job ad or send your CV across to me at e.ng@brunel.net for a confidential discussion.

(Brunel International South East Asia Pte Ltd, Registration Number: 199603098R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R2198025.)

Essential skills and knowledge 

What we offer 

your-application-process[1]

Application process

First Contact

We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days. 
 

Scheduling an Interview

After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview. 

Phone/ Qualification Interview

During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.

Meeting in Real Life

After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth  interview to review your communication and interpersonal skills.

Application for the Position

Submission of candidates resume for client’s approval and screening.

Do you have questions?

S

Singapore

+6565322480