- Represent the Quality function to provide software design quality assurance support in the design and development of medical device products and facilitate the application of design controls, cybersecurity and risk management activities of new and existing products.
- Support Design Quality Engineering Assignments for new and existing products/processes.
- Write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, and IVDR; and to provide training to process owners related to Quality Management System requirements, as necessary. By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing and design processes, inspection procedure and test procedures. Review and approve completed procedures to assure compliance with content and regulatory requirements
- *Ensure design documentation for new, existing and modified products is in compliance with the FDA Quality System Regulation, global regulations and software standards (e.g., adherence to IEC 62304, ISO 14971 and cybersecurity).
BASIC QUALIFICATIONS | EDUCATION:
- Bachelors' degree (B.S.) in a Science related field, or equivalent combination of education and experience *5+ years related experience and/or training in Quality and/or Development position in IVD/Medical Device industry.
- Significant experience with application of the FDA regulations and recognized standards (e.g., FDA 21 CFR 820.30, FDA 21 CFR 820.70, FDA 21 CFR Part 11, ISO 13485, IEC 62304 and cybersecurity) *Ability to travel up to 20% between Carlsbad and San Diego sites
- Experience supporting ISO 13485 inspections and FDA inspections.
- Working knowledge of quality techniques such as root cause analysis, 5 why's, and Ishikawa diagrams.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.