Quality Assurance Specialist (Medical Devices/ 6Months/ Up $7k)

Adecco; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A recruitment agency in Singapore is seeking a Quality Assurance Professional for a 6-month contract role in the medical devices sector. The ideal candidate will have at least two years of regulatory experience and a robust understanding of quality compliance within medical or pharmaceutical environments. The position involves ensuring product compliance, collaborating with teams on regulatory information, and conducting training sessions. Salary is up to $7000, depending on experience.

Qualifications

• Minimum 2 years of experience in Quality and Regulatory within Medical or Pharmaceutical industry.
• Good understanding of US, EU, HSA regulations.
• Ability to communicate effectively with Health Authorities.

Responsibilities

• Ensure compliance with Quality Systems during product development.
• Coordinate regulatory information with cross-functional teams.
• Conduct training sessions on Quality System requirements.
• Monitor updates on regulations affecting specifications.
• Handle regulatory filings and maintain documentation.

Skills

Quality and Regulatory experience

Good communication skills

Internal Audit experience

Job description

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

• Min 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

Job Description

• 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
• Establishes and manages Technical Files for low to high-risk medical devices, including:
  • Efficacy and stability data
  • Design history and development
  • Technical construction documentation
  • Risk management and clinical evaluation
• Essential Requirements checklist

Next Step

Prepare your updated resume, send to the following email:

[e-mail]

*Only shortlisted candidates will be contacted*

Amelia Lau An Qi

Direct Line: [phone]
EA License No: 91C2918
Personnel Registration Number: R1987023