Job Profile
We are seeking an accomplished Quality Professional to spearhead our quality initiatives in a fast-paced medical device start-up.
* Ensure seamless implementation and maintenance of the Quality Management System (QMS) aligning with ISO 13485, FDA 21 CFR 820, and relevant regulatory requirements.
* Oversee all aspects of internal manufacturing operations including batch release, in-process controls, and product inspections to guarantee exceptional quality standards.
* Provide strategic oversight for subcontract manufacturing partners encompassing audits, quality agreements, and supplier performance management to optimize partnerships.
* Lead internal and external audits, manage Corrective Action Preventative Actions (CAPAs), and drive continuous improvement across quality processes.
* Collaborate closely with cross-functional teams comprising R&D, engineering, and operations to provide quality input during project development and tech transfer.
* Serve as the quality lead for product lifecycle activities from development through commercialization ensuring adherence to regulatory requirements.
* Foster close collaboration with regulatory affairs to ensure alignment across compliance and submission activities.
About You
* Minimum 5 years' experience in quality assurance within the medical device industry preferably with Class II/III devices.
* Demonstrated working knowledge of ISO 13485, FDA QSR, MDR, and relevant global regulatory frameworks.
* Experience in both internal and contract manufacturing environments.
* A proven track record of building, maintaining, and improving quality systems in dynamic settings.
* PRACTICAL problem-solving skills coupled with excellent communication and collaboration abilities.
* Bachelor's degree in Engineering, Science, or a related technical field.
What We Offer
An Opportunity to Excel
The successful candidate will have the chance to work in a collaborative environment that fosters growth, learning, and innovation. As a key member of our team, you will be empowered to make meaningful contributions and shape the future of our organization.
Continuous Learning and Development
We are committed to supporting the ongoing education and professional development of our employees. This includes opportunities for training, mentorship, and networking within the industry.