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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.
The Impact You’ll Make in this Role
As aSenior 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:
– Implement quality activities aligned with division quality strategy to enhance customer satisfaction.– Establish and maintain the quality management system in to meet local countries Medical Device requirements- Ensure new or modified products to meet customer, regulatory, marketing requirements.– Lead the communication between lab and plant to minimize the lead time to resolve the issue and complaint sample analysis.– Establish supplier product quality plans to ensure the outsourced product to meet its requirements.– 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:
Additional qualifications that could help you succeed even further in this role include:
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.
Please access the linked document by clicking select the country where you are applying for employment, and review. Before submitting your application, you will be asked to confirm your agreement with the terms.
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