Quality Systems Specialist
2 weeks ago
This is a pivotal position that oversees the maintenance and improvement of the Quality Management System (QMS) across Leica Microsystems Commercial Offices in the APJ region. The ideal candidate will have proven experience in QMS and Regulatory Affairs, with a strong understanding of international regulatory requirements.
Responsibilities- Maintain QMS process compliance, ensuring seamless interactions with 3rd party auditors during site assessments.
- Drive continuous improvement of QMS processes, leveraging insights from internal audits to enhance overall effectiveness.
- Manage the QMS platform for quality document creation and training purposes.
- Collaborate with the APJ regulatory team on product registration activities, fostering positive relationships with government and regulatory authorities.
- Coordinate post-market surveillance activities, validating processes as needed to ensure QMS integrity.
- Minimum 2-3 years of experience in QMS and/or RA in a regulated industry.
- International experience in problem-solving, complaint handling, or equivalent.
- Bachelor's degree in science, engineering, or a related field.
- Approximately 25% of work involves travel.
- Familiarity with Australian medical device regulatory requirements is preferred.
- Knowledge of APJ region regulatory requirements is also desirable.
The successful candidate will be offered a comprehensive benefits package by Danaher, a leading operating company. For more information, visit Leica Microsystems' website.
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