Quality Assurance Specialist (Medical Devices / 6Months / Up $7k)
ADECCO PERSONNEL PTE LTDD09 Cairnhill, Orchard, River Valley, SG10 days ago
Job descriptionMin 2 years of Quality and Regulatory experience in Medical or Pharmaceutical industry Good understanding of US, EU, HSA and other regulations. Competent in communicating with Health Authorities and Authorised Agencies. Internal Audit experience with good knowledge of Singapore, Asia Pacific and European regulatory requirements Supports procedures to ensure compliance with Quality Systems and industry regulations during product development Collaborates with cross-functional teams and specification consultants to coordinate regulatory information Educates teams on Quality System requirements and conducts training sessions Monitors and communicates updates on relevant regulations affecting product specifications May handle regulatory filings and maintain documentation required by regulatory bodies Leads QMS / QSR awareness sessions for new hires Efficacy and stability data Design history and development Technical construction documentation Risk management and clinical evaluation Essential Requirements checklist Only shortlisted candidates will be contacted
Roles & Responsibilities
The Opportunity
- Exciting opportunity to work in an organisation manufacturing Medical Devices. You will be ensuring product compliance with Quality and Regulatory requirements throughout development and transfer to production, while maintaining an up-to-date Quality Management System aligned with current regulations.
- Monday - Friday / Office Hours
- Location : MacPherson
- 6 months contract (Convertible, subjected to performance and business directions)
- Salary : Up to $7000 (Subjected to experience)
The Talent :
Job Description
Establishes and manages Technical Files for low to high-risk medical devices, including :
Next Step
Prepare your updated resume, send to the following email :
amelia.lau@adecco.com
Amelia Lau An Qi
Direct Line : +65 6697 7987
EA License No : 91C2918
Personnel Registration Number : R1987023
Tell employers what skills you have
Pharmaceutical Industry
Construction
Quality Management
Quality Assurance
Quality System
GMP
Risk Management
Data Design
Compliance
Medical Devices
Audits
Product Development
Regulatory Requirements
Manufacturing
Qi
Audit
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Quality Assurance • D09 Cairnhill, Orchard, River Valley, SG
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