Job description

• The candidate must be able to provide solutions to a wide range of difficult problems, while ensuring that those solutions are compliant, innovative, thorough, practical and consistent withorganizational objectives.
• They will serve as the QA team member on cross-functional project teams;must be able to interact effectively with employees, manager, and cross-functional peers. They must beable to communicate confidently and effectively with management, peers, and key stakeholders.Design Control:
• The candidate will guide and influence on-market product cross-functional teamsthrough design, validation, and regulatory compliance and assure robust product vs. customerrequirements.
• The candidate should be able to assess manufacturing process changes and the impact toproduct.
• They should be able to formulate appropriate reasons and justifications for changes, includingassessment of crucial parameters and other affected systems/products. They should possess a thorough understanding of the design control lifecycle, including design inputs, verification, validation, and commercialization. Knowledge of application of IVDR standards to the design process a plus.Quality System:
• The candidate maintains and ensures compliance to the quality system that isappropriate for the unit specific medical device(s) designed or manufactured. They must be able toensure compliance to, and is able to demonstrate, knowledge of site level policies and procedures.

Education: Bachelor's degree in Life Science, Engineering, or closely related discipline.

• At least 5 yearswork experience in Quality or related field experience (diagnostic quality, technical area, etc); Less
• experience may be appropriate with advanced degree.
• Preferred experience in the Healthcare industry;
• preferred experience with assay development or assay support.