- Ensuring the company's commitment to the QMS.
- Leading the effort in the ISO 13485 and MDR documentation preparation for submission to NB.
- Preparing and reviewing product regulatory documentation submissions to international health agencies.
- Leading as the person-in-charge of internal audits and external suppliers/NB audits and acting as the person responsible for regulatory compliance (PRRC).
- Managing quality-related issues originating from internally, suppliers and customers.
- Reviewing and contributing to our products' Design and Development process in terms of procedures and documentation.
- Leading the QARA team and working with senior management to define and deliver the company's overall strategy based on quality and regulatory perspectives.
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quality assurance regulatory affairs manager -
Quality Assurance
Found in: Talent SG 2A C2 - 17 hours ago
N & N AGRICULTURE PTE LTD SingaporeRoles & Responsibilities · Job Description · Candidate must possess at least Diploma/Advanced/Higher/Graduate Diploma in Food Technology/Nutrition/Dietetics or equivalent. · Required language(s): bilingual (in order to handle queries and feedbacks from Mandarin and English speaki ...
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Quality Assurances
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Quality Assurance
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HS-CM ENGINEERING PTE. LTD. SingaporeRoles & Responsibilities · Responsibilities: · Responsible for assuring the implementation and compliance with the Quality Assurance System. · Control and monitor all activities related to Quality Management System (QMS). · Taking care of QA/QC documents of the entire project inc ...
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Quality Assurance
Found in: Talent SG 2A C2 - 17 hours ago
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Quality Assurance
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MIGHTY JAXX INTERNATIONAL PTE. LTD. SingaporeRoles & Responsibilities · Our Team · Mighty Jaxx is the leading integrated future culture platform in Southeast Asia today. With a mission to supercharge future culture phygitally, Mighty Jaxx's integrated platform will empower future pop culture brands with an end-to-end supply ...
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Quality Assurance
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Quality Assurance
Found in: Talent SG 2A C2 - 2 days ago
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Quality Assurance
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Quality Assurance
Found in: Talent SG 2A C2 - 17 hours ago
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Quality Assurance
Found in: Talent SG 2A C2 - 17 hours ago
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Quality Assurance
Found in: Talent SG 2A C2 - 1 day ago
TL PRECISION PTE. LTD. SingaporeRoles & Responsibilities · -Familiar with usage of commonly-used QC testing / measuring instrument · -Organised, methodical, meticulous, pro-active · -Visual Inspection · -Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are uphel ...
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Quality Assurance
Found in: Talent SG 2A C2 - 1 day ago
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Quality Assurance
Found in: Talent SG 2A C2 - 6 days ago
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Quality Assurance
Found in: Talent SG 2A C2 - 3 days ago
PADLET PTE. LTD. SingaporeRoles & Responsibilities · ABOUT PADLET · We are building more beautiful and fun alternatives to traditional documents. They're less of a pain-in-the-ass to create, and a lot less waterboard-y to view. Think Microsoft Office, but not as soul crushing.Over ten million people use P ...
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Quality Assurance
Found in: Talent SG 2A C2 - 1 day ago
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Quality Assurance
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Quality Assurance
Found in: beBee S2 SG - 4 days ago
VIVO SURGICAL PRIVATE Singapore Full time· About UsVivo Surgical is Southeast Asia's pioneering surgical technology disruptor, engaged in developing innovative medical device solutions for better surgeries. An ISO 13485 certified company with international accreditations such as the US FDA and EU CE Mark, our products ...
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Quality Assurance
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Avetics Global Pte Ltd Singapore InternshipQuality Assurance & Control Intern · Production, Testing and QC of Unmanned Aerial Vehicle System · Job Scope · 1. UAV related system production and testing · a) Produce UAV related system · b) Fabrication of UAV related system prototypes and tests in a real world environment. · ...
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Quality Assurance
Found in: beBee S2 SG - 2 days ago
Mighty Jaxx Singapore InternshipYour Role · Mighty Jaxx is looking for a Quality Assurance (QA) Test Intern to join the Engineering team in an exciting website revamp project. · We are looking for a full-time intern, who is able to join us from May 2024 onwards, ideally for a period of a minimum of 3 months. · ...
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Quality Assurance Engineer
Found in: Talent SG 2A C2 - 1 day ago
DYSON SPHERE NEW ENERGY PTE. LTD. SingaporeRoles & Responsibilities · We are seeking a skilled Quality Assurance Engineer to join our team. The ideal candidate will have a strong background in quality assurance methodologies, testing techniques, and automation tools. The Quality Assurance Engineer will play a key role in ...
Quality Assurance - Queenstown, Singapore - VIVO SURGICAL PRIVATE
Found in: beBee S2 SG - 5 days ago
Description
LocationSingapore, Central Singapore
Planning Area
QUEENSTOWN
Job Type
Full Time
Salary
$7,500 - $8,500 Per Month
Date Posted
4 hours ago
Expiry Date
01-Jul-2022
Additional Details
Job ID
223898
Job Views
1
Roles & ResponsibilitiesAbout UsVivo Surgical is Southeast Asia's pioneering surgical technology disruptor, engaged in developing innovative medical device solutions for better surgeries. An ISO 13485 certified company with international accreditations such as the US FDA and EU CE Mark, our products target the medical needs of the world through innovative applications of science & technology.
Our technologies redefine healthcare accessibility, allowing for widespread adoption of such modalities to improve patient outcomes. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and minimally-invasive robotic surgery, which are strategically co-developed with leading healthcare institutions and KOL collaborators in territories such as the USA, UK, France, Germany, Brazil, Vietnam and Singapore.
Join us as we build towards our vision of being the Asia Pacific's leading medical device developer and manufacturer in surgical technology and robotics.
About The RoleWe value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company's commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products' regulatory strategies and submissions to various regulatory bodies around the globe. Your role will enable you to work not only with diverse functions within the Vivo Surgical team but also in close tandem with our external partners such as the suppliers, distributors and Notified Body (NB).
Your responsibilities shall include the following:
