Senior Quality Assurance Executive

2 weeks ago


Singapore RESTALYST PTE. LTD. Full time
Roles & Responsibilities

Job Description

The primary job responsibility is to maintain and undertake the quality system ISO 13485 and related activities in an IVD medical device manufacturing facilities.

Education and Experience

  • Degree in Biochemistry, Biotechnology, Biomedical Sciences or Molecular Biology or other related disciplines from an accredited institution.
  • Minimum two years of relevant experience is preferred.

Responsibilities

  • Ensure that processes and activities needed for quality assurance are established, implemented and maintained.
  • Review and develop new processes and activities to ensure compliance to regulatory requirements.
  • Responsible for the results of the quality assurance processes and activities, associated documentation and compliance.
  • Prepare and submit quality documents required.
  • Undertake tasks assigned by management.

Skills, Knowledge and Abilities

  • In depth knowledge of QMS, ISO 9001, ISO 13485, ISO 14972.
  • Goal-driven person.
  • Excellent written and oral communication skills.
  • Strong interpersonal skills.
  • Meticulous, independent and resourceful.
  • Strong initiative and high professional conduct.
  • Ability to multi-task and adapt in a dynamic environment.
Tell employers what skills you have

Biochemistry
Ability to Multitask
Management Skills
Oral Communication Skills
Food Safety
Quality Management
Quality Assurance
Quality System
Interpersonal Skills
ISO
Protocol
Biotechnology
Compliance
Project Management
Attention to Detail
ISO 9001
Audits
Molecular Biology
Regulatory Requirements
Manufacturing

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