Job Description:
We are currently seeking a highly skilled and experienced individual to join our team as a Senior Quality Engineer. In this role, the successful candidate will play a crucial role in ensuring product quality assurance support for Medical Products and management of quality system to meet Medical Device regulatory requirements
The ideal candidate for this position will have a strong background in quality engineering within the Medical Device industry with a deep understanding of ISO 13485 requirements, Medical Device requirements in SEA countries. They should possess excellent communication and leadership skills, with the ability to collaborate effectively with cross-functional teams. Strong analytical and problem-solving abilities, along with a commitment to continuous improvement, are also essential.
Assumes responsibility for performing and guiding approved self-initiated quality activities leading to innovative applications and extensions of existing and new quality programs of importance to a division. Usually reports to a quality supervisor or manager, or senior technical individual.
Collaborate with Innovative 3Mers Around the World
Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers.
This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.
The Impact You’ll Make in this Role
(Also known as job summary and primary responsibilities. Do not alter standard text of the introductory paragraph, except for adding in the titles of the position. No more than 5 bullet points should be used to articulate the responsibilities.)
As a Senior Quality Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
Working closely with manufacturing, laboratory, and regulatory functional leaders locally and globally, to drive standardization for processes and records related Medical Products. This includes ensuring that all QMS related activities are followed and consistently implemented to ensure compliance with country specific Medical Device requirements.
Key responsibilities of the Senior Quality Engineer will include:
Enhancing Customer Satisfaction – Implement quality activities aligned with division quality strategy to enhance customer satisfaction. Quality System Leadership – Establish and maintain the quality management system in to meet local countries Medical Device requirements Leading Quality Qualification in New Product and Product Change Projects - Ensure new or modified products to meet customer, regulatory, marketing requirements. Resolving Quality Issue – Lead the communication between lab and plant to minimize the lead time to resolve the issue and complaint sample analysis. Supplier Product Quality Management – Establish supplier product quality plans to ensure the outsourced product to meet its requirements. Product quality – Support product quality such as design issue follow-up, sampling plan revisit for product release, document revision, etc.
Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
- Bachelor’s degree or higher in an engineering or science discipline (completed and verified prior to start) from an accredited institution
- Three years of combined experience in a Manufacturing, Production, Quality and/or Laboratory role in a private, public, government or military environment
- 5 years of Experience in Medical Device industry
Additional qualifications that could help you succeed even further in this role include:
- Bachelor’s degree or higher in a Science, Technology, Engineering or Mathematics (STEM) or related discipline from an accredited university
- Experience in Medical Device QMS – ISO 13485, MSAP, MDD, GDPMD regulations
- Certifications in quality engineering, quality auditing or quality management according EOQ standard or comparable
- Microsoft Office proficient
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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