Deskripsi Pekerjaan
Are you a seasoned Quality Assurance professional looking to bridge the gap between groundbreaking research and real-world medical application? The Agency for Science, Technology and Research (A*STAR) is seeking a Senior Design Quality Assurance Manager to join our MedTech Catapult initiative.
In this pivotal role, you will lead quality strategy for next-generation medical devices. You will partner with multi-disciplinary engineering and clinical teams to ensure that our innovations not only meet rigorous global regulatory standards (such as ISO 13485 and FDA 21 CFR Part 820) but are also optimized for seamless commercialization. This is an exceptional opportunity to influence the MedTech landscape in Singapore and beyond, ensuring that patient safety and product efficacy remain at the heart of our development lifecycle.
We offer a collaborative, mission-driven environment where your expertise in design controls and risk management will directly impact the speed-to-market for life-saving technologies.
Tanggung Jawab
- Oversee the implementation of Design Controls throughout the product development lifecycle for diverse MedTech projects.
- Lead internal and supplier audits to ensure strict adherence to ISO 13485 and global regulatory compliance.
- Drive comprehensive Risk Management activities (ISO 14971) from concept through to clinical validation.
- Collaborate with cross-functional R&D and engineering teams to integrate quality-by-design (QbD) principles early in the development phase.
- Manage the creation and maintenance of Design History Files (DHF) and Technical Files for regulatory submissions.
- Champion continuous improvement initiatives to streamline internal quality management systems.
- Act as the primary point of contact for external regulatory bodies during product certification processes.
Kualifikasi
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
- Minimum of 8-10 years of experience in Quality Assurance within the medical device or MedTech industry.
- In-depth knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820/821 requirements.
- Proven track record in managing regulatory submissions and securing market clearances.
- Strong expertise in design verification and validation (V&V) protocols.
- Excellent communication and leadership skills, with the ability to influence technical and non-technical stakeholders.
- Professional certifications such as ASQ Certified Quality Engineer (CQE) or Lead Auditor status are highly preferred.