Quality Assurance Professional
This role is responsible for leading the implementation and maintenance of our Quality Management System, focusing on continuous improvement through process optimization and effective quality control.
* Drive QMS implementation and ensure delivery of overall quality strategy by collaborating with cross-functional teams and stakeholders.
* Interpret relevant industry standards and regulations to ensure compliance and adherence to quality best practices.
* Develop and review test specifications, part specifications, and design specifications to ensure they meet our quality requirements.
* Provide QA and Design Assurance expertise to support product development and manufacturing processes.
* Support supply chain activities, including process development and requirements definition.
* Coordinate internal audit programs, material review boards, and complaint processes to ensure timely and effective resolution.
The ideal candidate will have a strong understanding of medical device regulations, including FDA guidelines and ISO 13485. Relevant experience includes working in regulated environments, managing change control processes, and supporting clinical investigations.
Required Skills and Qualifications
* Proven track record in quality management and assurance.
* Strong knowledge of regulatory requirements, including FDA and ISO 13485.
* Excellent communication and collaboration skills.
* Ability to interpret and apply regulatory requirements to ensure compliance.
* Proficiency in quality management software and tools.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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