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    • You should have at least 1 year of regulatory experience in medical devices and a related science degree.
    • Partnering with a global Medical Device MNC with an…
    • 3–8 years of experience in quality engineering within the medical device/pharmaceutical/healthcare industry .
    • We are seeking a detail-oriented Quality Engineer…
    • Strong skills in quality reporting, FA/NPI processes, and CMM inspection.
    • Quality System & Audits: Act as Management Representative (MR) for ISO 9001; lead…
    • Consolidates and reports quality results.
    • Assists with development and implementation of quality audits.
    • Assures data availability and integrity for all quality…
    • Perform root cause analysis and identify corrective and preventive actions in addressing quality events.
    • Comply to all policies and standards.
    • Experience: Minimum of 6 years of experience in a medical device manufacturing environment in a quality-related role, with practical experience in supplier…
    • Knowledge of ISO 9001 , quality assurance systems, and manufacturing quality processes.
    • Perform process inspections, product verification, and quality control…
    • Detail-oriented, organized, and comfortable working within structured quality and compliance environments.
    • Review qualification and validation documentation to…
    • Study and improve production quality yield for each status of sample.
    • Experience with new product quality handling and control from development stage until mass…
    • Develops and applies quality standards in accordance with company and customer requirements.
    • Develops and conducts related tests.
    • The Lead Quality Engineer will be the onsite quality focal, driving the implementation of strategic quality initiatives and accelerating the maturation of the…
    • As our QA/QC Engineer, you hold a crucial role in strengthening the quality standards of the organisation, through effective implementation of quality…
    • Degree in Engineering or science, with 2 – 5 years of progressive Quality responsibility, preferably Supplier Quality in medical device / pharmaceutical…
    • To facilitate continuous improvement initiatives, by providing on the floor support through use of quality tools and coaching teams to build ownership and…
    • Minimum 3 years of experience in a quality assurance environment in manufacturing industry.
    • Lead and supervise CMM inspectors and quality technician in in-…

Job Post Details

Regulatory Affairs & Quality Assurance Executive [Medical Device / Up to 5,500] - job post

INTEGRITY PARTNERS PTE. LTD.
Singapore
$4,000 - $5,500 a month - Permanent
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Job details

Pay

  • $4,000 - $5,500 a month

Job type

  • Permanent

Location

Singapore

Full job description

  • Regulatory Affairs & Quality Assurance Executive with global Medical Device MNC
    • Opportunity to work on local and regional submissions


Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive .


Reporting to the RA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

  • Change control activities
  • Product promotional activities
  • Product registration
  • Product labeling
  • Regulatory inspections and audits

You should have at least 1 year of regulatory experience in medical devices and a related science degree.


For more information, please apply with your updated CV (in Word document).


Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

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