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QA / QC Assistant Manager ($4K to $4.5K) - Pharma / Medical Industry job in Orchard at Recruit Express Pte Ltd

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QA / QC Assistant Manager ($4K to $4.5K) - Pharma / Medical Industry at Recruit Express Pte Ltd

QA / QC Assistant Manager ($4K to $4.5K) - Pharma / Medical Industry

Recruit Express Pte Ltd Orchard Permanent
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  • Update the relevant standards, regulatory guidelines and essential requirements into the established medical device QMS.
  • Preparation of Technical File, Post Market Surveillance, PMCF, PSUR, Essential Requirements and work towards MDR certification.
  • Participate in the internal and external quality audits, and inspections.
  • Review and update SOPs to ensure compliance with regulatory and ISO13485 standard requirements.
  • Communicate any changes in market regulatory requirements to all relevant functions with an action plan and timeline for implementation.
  • Certified and practicing ISO 13485 internal auditor with experience in MDR.
  • Experience in Risk Management implementation of ISO14971 in all aspects of QMS.
  • Challenges of Position – The position requires the incumbent to be self-motivated to keep up with the current regulations and standards requirements and independent decision-making.
  • Measurement – The incumbent will be measured by success in achieving good QA and Regulatory affairs’ results in successful product registrations, regulatory audits and good product quality.
Job Requirements:
  • Min. Diploma/ Degree in science courses 
  • Min. 2-3 years of relevant experience
Salary range: $4K to $4.3K 
Interested candidates, please forward your resume to [ Email address blocked ]  
Consultant: Huang Jingsheng Kevyn (R1333338) 
Recruit Express Pte Ltd (99C4599) 

Recommended Skills

  • Iso 13485
  • Internal Auditing
  • Iso 13485 Standard
  • Auditing
  • Product Quality Assurance
  • Software Quality Assurance (Sqa)

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