Manager, Product Assurance

The Product Assurance Manager, is responsible for leading all related product assurance activities in support of Renal Solutions product development

Embrace, promote, and support the Quality Assurance and Regulatory Affairs mission
Lead the design verification and validation efforts of Renal Solutions electromechanical and disposable medical devices. These efforts include testing in the areas of functional safety, system-level, electronic hardware, embedded firmware, software, mechanical, environmental, reliability, failure mode, and usability, as appropriate.
Plan, coordinate and manage the activities of all Product Assurance associates in support of Renal Solutions product assurance efforts. Ensure the timely completion of these activities.
Review and provide input on product design requirements to ensure design specifications are challenged with suitable and achievable acceptance criteria.
Serve as subject matter expert in the area of test methodology and techniques in support of Renal Solutions development and manufacturing organizations.
Implement and consider the product risk profile when developing all product assurance testing activities. This includes the application of risk management tools and methodologies.
Develop and implement appropriate solutions for testing: automated, manual, outsourced, or in-house.
Employ customer focus, cross-functional collaboration/teamwork skills, continuous innovation and improvement, and sound judgment.
Assist in the management of the software quality assurance activities in conjunction with the Engineering Group.

Education:

Minimum of seven years of design verification and validation
Quality / Regulatory experience in an FDA regulated industry.
Working knowledge of FDA Quality System Regulation, Medical Device Directive, CDMCAS requirements and ISO13485:2003 is required.
Demonstrated competency with the application of 21CFR Part 820.30, Design Controls and ISO13485:2003 section 7.3., with focus on design verification and design validation.
Knowledge of ISO14971:2000, Application of risk management to medical devices.
Excellent technical writing, communication and interpersonal skills is required
Knowledge of statistical analysis techniques and statistical software is required.
Experience handling multiple concurrent project assignments, and successfully teaming with cross-functional project teams is required.
Proven ability to foster teaming within the responsible group.

Interested parties should submit their resume to careers@renalsolutionsinc.com.