PROJECT DESCRIPTION:
PreciX is a Singapore-based MedTech startup founded in 2016 to revolutionize the healthcare industry's approach to joint health and mobility assessment, transforming lives by helping people move better and live well. We provide simple, fast, and accessible assessments, and empower healthcare providers to improve patient outcomes and reduce costs.
We have developed a novel wearable device, GATOR PODs, for the knee joint. This device aims to provide a range of biomechanical measurements, by leveraging a modular and scalable multi-sensor platform. These measurements are used by the clinician to assess the functional performance of the knee joint accurately during natural dynamic movement, thereby enabling a range of clinical applications such as screening, diagnosis support, and recovery tracking.
We are seeking a highly motivated candidate keen on working in healthcare and deeply passionate about Data to join our team. The ideal candidate will have strong Python skills and be proficient in running existing Python pipelines to generate reports.
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.
Related Company Review:
PreciX (Singapore)
www.precix.ioPros: Very closely knitted company culture due to having a small team.
Cons: A role with higher position is required to cover multiple roles compared to bigger companies
Related Job Searches:
- Company:
PreciX Pte Ltd - Designation:
Quality Assurance & Regulatory Affairs Intern - Profession:
Others / General Work - Industry:
Manufacturing General / Biomedical / Pharmaceutical - Location:
Bukit Merah