Quality Assurance Engineer

2 weeks ago

Singapore HOYA MEDICAL SINGAPORE PTE. LTD. Full time

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 materialssuch as product labels and package inserts across diffferent 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.
- 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.

**Education**:

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

**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.

**Skills / Knowledge / Ability**:

- Preferably with basic knowledge in packaging and labeling standards/reguirements.
- Basic knowledge of labeling process, translation, labeling graphics design and proofreading systems.
- Knowledgable 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.

**Computer Skills**:

- Proficient in Microsoft Office
- Basic skills in labeling software

**Languages**:

- Able to speak and write fluently in English.

**Travel Requirement**
- 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.

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