Job Description

Location: Bayan Lepas, Penang
s:

• Ensure validation protocols (IQ, OQ, PQ) comply with quality standards as well as FDA 21 CFR Part 820 and ISO 13485 regulations.
• Develop, update, and maintain Master Validation Plans and associated reports.
• Evaluate validation data to verify it aligns with required specifications.
• Work closely with cross-functional teams (Quality, Engineering, Manufacturing) to execute product performance qualifications.
• Assist with projects and process changes by reviewing and determining validation requirements.

Job Requirements:

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

Others Information:
For those who have what it takes, please send in resume to:
Recruitment Consultant : Lara
Email :
Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd
Lot No.28-03, 28th Floor, Public Bank Tower,
No.19, Jalan Wong Ah Fook, 80000 Johor Bahru, Johor.
Tel : 607 -2233 228

Skills Required