Job Responsibilities:
- Participate in new/modified product development projects and support deliverables required for each design phase (e.g., Product specification establishment, sterilization validation etc.).
- Evaluate product related changes initiated by R&D / Contract manufacturer.
- Assist with the development of the required documentation/justification to support proposed change.
- Support and provide inputs to product related issue such as CAPA, Supplier CAPA, non-conformity and complaints.
- Analyze and track product quality data/metrics in support of Quality Objective and Management Review.
- Support the quality system implementation projects and support the supplier audits and external regulatory body audits.
Job Requirements:
- Bachelor's degree or Diploma in Science, Engineering, Quality or relavent qualification.
- Min 3 - 4 years of experience in quality, R&D or manufacturing function in the medical device industry.
- Good understanding of the ISO 13485, EU Medical Device Directive/EU Medical Device Regulations and FDA QSR Part 820.
- Preferably to have relevant experience in manufacturing, product validation, gamma/EO Sterilization and statistical analysis.
Interested applicants, please APPLY or email to your CV to us.
We regret that shortlisted candidates will be notified.
Name: Kyle Lim Ji Pang
Registration No.: R21103327
EA License No.: 02C3423
Kyle Lim Ji Pang License No.: 02C3423 Personnel Registration No.: R21103327
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