.Implement and support the Quality Assurance system to ensure compliance with ISO13485, 21 CFR 820, EU MDD, MDSAP, LVD, EMC, RED, etc.
Define and write documents, including procedures, work instructions, and quality records, to meet regulatory requirements and product standards.
Collaborate with cross-functional teams to understand and document processes for product development, manufacturing, and post-market activities.
Drive tasks end-to-end, ensuring all quality-related activities are completed in a timely manner.
Stay updated on regulatory changes and proactively implement them within the Quality Management system (QMS).
Support and manage Notified Body audits and FDA inspections, ensuring readiness and successful outcomes.
Work closely with stakeholders to address non-conformities, implement corrective actions.
Requirements: Practical engineering degree or higher, with a Bachelor's degree in a relevant field preferred.
Minimum of 5 years' experience in the medical device industry, with a focus on implementing and supporting Quality Assurance systems.
Strong understanding of ISO13485, 21 CFR 820, EU MDD, and MDSAP.
Proficient in defining and writing documents, such as procedures, work instructions, and quality records.
Experience with Notified Body audits and FDA inspections is highly desirable.
Knowledge of LVD, EMC, RED, RoHS, and Reach is preferred.
Excellent communication and documentation skills, with keen attention to detail.
Results-driven, able to work effectively under pressure and meet deadlines.
Demonstrated ability to present technical information and collaborate in a team environment.
Self-motivated, proactive, and quick self learner, with the ability to adapt to changing.
This position is open to all candidates.
