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.
Job Summary
The Senior QA Engineer is responsible for supporting the Director 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 Engineer shall oversee the validation and verification activities for medical devices and manufacturing processes.
Reporting
The Senior Quality Assurance Engineer reports to the Director of QARA.
Responsibilities
* Ensure products are maintained throughout their lifecycle and comply with global standards.
* Assess risk for process changes and provide QA technical direction for qualification and validation activities.
* Work with the Director of QARA to present information clearly as part of monthly quality forums and management review meetings.
* 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.
* Review and approval of process validation and design verification protocol and reports in accordance with applicable standards and regulatory requirements.
* Oversee supplier qualification and audits.
* Own and manage NC and CAPA activities.
* Understand and apply risk management concepts per ISO 14971:2019 and ISO 13485:2016 requirements.
* 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.
Qualifications
* Minimum of 7 years’ experience in a Quality Assurance or Design Assurance role.
* Degree in Science, Engineering or a related field.
* Certified ISO 13485 internal or lead auditor (preferred).
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