Rotate Device

Job Openings

Quality Assurance Engineer/Senior Engineer (Labeling and Projects)

Role
Quality Assurance
Location

Singapore

Singapore
Job Description

This position is a global position, responsible for delivering successful labelling changes for new and existing products through new labeling or labeling change process. These include executing all activities necessary to generate or revise and ensure the integrity of regulated labelling materials such as product labels and package inserts across different regions, for all HSO products and perform reviews and First Article (FA) inspection to confirm the information is accurate and in compliance with global and regional standards and regulations. This position shall also support new material/component qualification as part of business continuity/sustainability.

 

Key Duties & Responsibilities

  • Responsible for product labeling deliverables through collaboration with cross-functional subject matter expert (SME)
  • Plan and manage the development of product labeling content, graphics, translations, and labeling specifications for multiple projects across the different project timelines and product requirements
  • Manage new labeling or labeling change process for any new or revised labelling content
  • Responsible for timeliness of labeling deliverables for Regulation (EU) 2017/745 (MDR) transition and subsequently any MDR labeling updates
  • Support MDR regulatory submission for labeling
  • Maintain, improve and execute translation or translation verification process as needed
  • Drive and propose new labelling approaches towards labeling improvement process, cost savings, reduction in SKU, etc.
  • Support CAPA activities for labeling issues where applicable
  • Lead labeling development as project core team and/or sub-team member for new product development by Project Director
  • Independently plan and support qualification/implementation of new material/component related to labeling/packaging where applicable
  • Constantly review and support introduction of new technologies to enhance or improve product labeling development
  • Perform any other job/task as assigned by supervisor

 

Experience

  • At least 3 years of experience in a manufacturing industry preferably in medical device or pharmaceutical industry and / or relevant experience in quality assurance management or project management

 

Education

  • Bachelor degree in science or engineering field (applied chemistry, biomedical engineering, material science and engineering, mechatronics, microbiology etc.)

 

Skills / Knowledge / Ability

  • Preferably with basic knowledge in packaging and labeling standards/requirements
  • Basic knowledge of labeling process, translation, labeling graphics design and proofreading systems
  • Knowledgeable in ISO 13485, Regulation (EU) 2017/745 (MDR) and 21 CFR Part 11, Part 820 and Part 830 regulations
  • Ability to make informed decisions and work well with different stakeholders
  • High level of detailed accuracy and attention to details
  • Excellent verbal and written communication skills
  • Self-motivated and able to work independently
  • Proficient in Microsoft Office
  • Basic skills in labeling software

 

Languages:

  • Able to speak and write fluently in English

 

Travel Requirements

  • Ability to travel up to 15%, mainly to support project, supplier qualification or audit

 

Working Conditions

  • Position is based in normal office settings and on the shop floor, including clean room environments

 

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy, which can be found here.

 

We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.

Apply Now or E-Mail your resume to hso-ghq-hr@hoya.com; subject “Application for 'Job Title'”. Thank you!