Job Description

s:

Ensure that validation procedures (IQ, OQ, PQ) meet quality standards and comply with FDA 21 CFR Part 820 and ISO 13485 regulations. Create, update, and maintain Master Validation Plans and related reports. Review validation data to confirm it meets required specifications. Collaborate with Quality, Engineering, and Manufacturing teams to carry out product performance tests. Support projects and process changes by identifying and implementing necessary validation steps.

Job Requirements:

Bachelor's degree in Engineering (Mechanical, Science, Biomedical, or related field). At least 1 year of validation experience in a regulated industry (medical devices preferred). Good knowledge of IQ/OQ/PQ processes and the validation lifecycle. Understanding of cGMP, FDA, ISO 13485, and EU MDR requirements. Familiarity with statistical analysis and risk management tools (FMEA, PFMEA). Strong documentation and technical writing skills.

Fresh Graduates are welcome to apply.*

For those who have what it takes, please apply online or send in your profile to:

Consultant: Lara

Email: Lara@brightprospect.com.my

Tel : 07-2233 228

For more job opportunities, please visit https://www.brightprospect.com.my/

OUR SERVICE FOR JOB SEEKER IS FREE!

Job Type: Full-time

Pay: RM4,000.00 - RM6,000.00 per month

Benefits:

Free parking Health insurance Opportunities for promotion Professional development
Application Question(s):

Do you have experience in validation protocols (IQ, OQ, PQ)? (Yes or No) Do you have understanding of FDA 21 Part 820, ISO 13485, cGMP, and EU MDR requirements in validation work? (Yes or No)
Experience:

validation: 1 year (Preferred)
Work Location: In person