Company Description
Salt Medical is an international medical device CDMO company with a wide-reaching global R&D and manufacturing network. With R&D centers in Ireland and the U.S., and large-scale manufacturing centers in the Asia-Pacific region, Salt specialises in catheters, guidewires, medical endoscopes, surgical robots, and other innovative products. The company has extensive experience in designing, developing, and producing innovative products for cardio, neuro, and endovascular applications, as well as digestive, respiratory, and other clinical areas. Our synergistic network ensures cost-effective and responsive services for global medical device manufacturers.
Introduction
The Senior QA Engineer is responsible for supporting the VP of QA RA in developing, implementing, and maintaining procedures and processes in the company's QMS to ensure compliance with the relevant regulations. The Senior QA Engineer provides support for device development, new product introductions, reviewing technical documentation, participating in design reviews, and ensuring compliance with design control requirements throughout the PDP lifecycle. The Senior QA RA shall oversee the validation and verification activities for medical devices and manufacturing processes.
Reporting
The Senior Quality Assurance Engineer reports to the VP of QA/RA.
Responsibilities
* Ensure products are maintained throughout their lifecycle and comply with global standards.
* Assess risk for design changes and provide QA technical direction for qualification and validation activities.
* Work with the VP of QARA to present information clearly and minimize agency questions.
* Establish strong relationships across the organization and with customers and suppliers in a complex technical environment.
* Maintain up-to-date knowledge of regulatory compliance for product design, development, and commercialization.
* Collaborate with engineering and manufacturing to ensure quality standards, conduct tests, and perform statistical analysis.
* May focus on design, material, production control, product evaluation, reliability, inventory control, or R&D as they apply to quality.
* Understand and apply risk management concepts to meet FDA, ISO 14971:2019, and ISO 13485:2016 requirements.
Competency Requirements: qualifications & experience
* Regulatory Knowledge: expertise in FDA, ISO 14971:2019, and ISO 13485:2016 requirements.
* Technical Direction: ability to provide QA technical input for qualification and validation activities.
* Design Verification: experience in generating protocols and reports
* Cross-Functional Collaboration: strong ability to work across various functions and establish effective relationships.
* Quality Assurance: proficiency in conducting quality assurance testing and performing statistical analysis.
* Minimum of 10 years' experience in a Quality Assurance or Design Assurance role
* Degree in Science, Engineering or a related field