Supports the manufacture and development of medical device processes. Specific support of reliability, quality, packaging, labeling, sterilization, pyrogen, and shelf life issues.
Will work with Manufacturing, Production and other Quality Assurance areas to resolve product and process quality issues.
Supports manufacturing process changes, product design improvements and the implementation of new products or processes. Job duties :
Works with Manufacturing Engineers to review process changes and resolve product quality issues.
Works with suppliers to maintain high quality levels of incoming production materials.
Leads and / or supports process, product and / or equipment validation activities (IQ, OQ, PQ). Executes equipment validation activities if required.
Obtains, analyzes and presents to management the key performance indicators related to quality process.
Works with R&D Engineers to support implementation of new products by reviewing quality and testing plans.
As assigned, maintains various Quality Systems such as CAPA, complaints, non-conformance, supplier quality, equipment calibration, internal auditing and quality metrics data analysis.
Develops, selects and tests packaging materials for new products.
Improves packaging on existing products.
Designs and supervises packaging testing.
Develops and implements product labels and instructions for use.
Performs additional duties as assigned.
Bachelor’s degree in related field or equivalent.
Minimum of seven (7) years of related experience.
Experience leading projects.
Ability to problem solve, with a can do approach.
Good communication skills.
Knowledge of medical device labeling requirements and methods for implementation.
Knowledge of medical device sterilization and pyrogen testing requirements.
Knowledge of medical product manufacturing.
Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).
Ability to understand the technology related to MicroVention’s products.
Ability to read and prepare technical documentation.
Experience developing and executing related protocols.
Computer skills including Word, Excel and CAD.