Quality Assurance

4 days ago


Singapore PreciX Pte Ltd Full time

ROLES AND RESPONSIBILITIES: 

  • Assist the Quality Assurance and Regulatory Affairs (QA/RA) department in matters related to its 13485 Quality Management System (QMS), ensuring all departments carry out the due processes and documentation required to ensure quality in all areas related to the medical device i.e., design and development, production, and software. 
  • Assist in managing documentation processes, such as reviewing and updating Quality (Standard Operating) Procedures, work instructions, and forms. 
  • Lead dedicated initiatives on behalf of the QA/RA department to understand the needs of different departments in the company and improve the suitability and adequacy of Quality (Standard Operating) Procedures throughout the company. 
  • Assist in the QA/RA department in preparing the company for related activities such as QMS Internal and External Audits, Bi-Annual Management Reviews etc. to ensure compliance with regulatory requirements and identify opportunities for improvement.
  • Carry out regulatory research and prepare for regulatory submissions, such as 510(k) submissions, technical files and design dossiers, under the guidance of the QA/RA department. 
  • Assist in risk management activities such as conducting risk assessments, reviewing, and updating risk management plans, and maintaining risk files. 
  • Assist in post-market surveillance activities such as complaint investigations, adverse event reporting, and trend analysis. 
  • Perform other duties as assigned, including ad hoc tasks as needed. 

LEARNING OUTCOMES & OBJECTIVES: 

  • By the end of this internship, you should have: 
  • Understood the necessary processes in a Medical Device company, to ensure quality in all areas such as design, development, production, deployment, and maintenance. 
  • Gained an appreciation of the work and coordination needed to seek regulatory approvals for a Medical Device system. 
  • Gained and applied project management skills throughout your tenure with us. 

REQUIREMENTS: 

  • Good verbal and written communication skills are necessary to coordinate multiple stakeholders within the company.
  • Strong research and analytical skills, to derive key insights and relational points from multiple substantial bodies of texts.
  • Ability to understand competing requirements and demands within the company and strategize and priorities/ recommend actions and initiatives that will maximize utility.
  • Ability to speak and present both internally and externally on matters related to QA and RA.

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