Director of Quality Assurance - US Medical Device

caliber8; Singapore; On-site; SGD 120,000 - 150,000; Full time

Job summary

A leading medical device company is seeking a Director of Quality Assurance based in Singapore. This pivotal role involves ensuring compliance with various regulatory standards and improving quality systems. Candidates should have over 15 years of experience in quality assurance within the medical device industry, strong leadership skills, and the ability to collaborate globally. Singaporeans or PRs are preferred for this position.

Qualifications

• 15+ years of strong experience in QA in the medical device industry.
• Ability to lead and inspire a global team.
• Must be a strong business partner.

Responsibilities

• Develop, maintain, and improve quality systems.
• Ensure compliance with the Quality Management System (QMS).
• Advocate continuous improvement in manufacturing and distribution.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Education

Bachelor of Science, Engineering, or Life Sciences

Job description

Director of Quality Assurance - US Medical Device MNC

Our client is an established medical device listed US MNC with one of their largest manufacturing plants globally based in Singapore. As part of internal movements we are seeking an experienced Quality Assurance leader to be a part of this set up.

This role will be reporting into the Global head of quality based in the US.

Main Role:

Develop, maintain and improve quality systems and assure products meet established specifications and are in compliance with various regulatory standards.

Major Accountabilities:

• Ensure compliance in the implementation and execution of the Quality Management System (QMS) to the current regulations (US FDA 21 CFR 820, 210 and 211, ISO/EN ISO 13485, EU Medical Device Directive (Council Directive 93/42/EEC as amended), EU Medical Device Regulation (REGULATION EU 2017/745), Japanese QMS Ordinance (MHLW MO 169), Canadian Medical Device Regulations (CMDR) (SOR/98-282), Brazilian Good Manufacturing Practices (RDC ANVISA 665/2022), and Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3) and other applicable regulations).
• Appointed Site Management Representative that has responsibilities and roles defined on the appointment letter.
• Appointed delegate Person Responsible for Regulatory Compliance (PRRC) that has responsibilities defined on the appointment letter.
• Demonstrate strong and visible support for the Quality Management System, ensure its implementation throughout their organization and advocate continuous improvement.
• Ensure products comply with market authorization and GMP requirements and advocate continuous improvement during manufacturing, distribution and shelf life, both for products manufactured at the site and for Third Party products managed by the Site or Functional Unit.
• Ensure management training on and awareness of quality and compliance requirements and systems.

Qualifications:

• Bachelor of Science, Engineering, or other Life Sciences related qualifications
• 15+years with strong experience in QA in the medical device industry coupled with relevant RA related roles will be a big help.
• Ability to lead and inspire a team across the globe will be key
• Must be a strong and able business partner.

Singaporeans or PR preferred: