Lead multiple quality projects and activities to support the packaging and labeling requirements of medical products, including, but not limited to, validation and re-validation activities.
Provide technical leadership for labeling control activities. Support manufacturing process changes, product design improvements, and the implementation of new packaging, labels, or processes.
Work with Manufacturing, Production, and other Quality Assurance areas to resolve product and process quality issues related to packaging and labeling. Job duties :
Work with Manufacturing Engineers to review process changes and resolve product quality issues.
Work with suppliers to maintain high quality levels of incoming production materials.
Lead and / or support process, product and / or equipment validation activities (IQ, OQ, PQ). Execute equipment validation activities as required.
Obtain, analyze, and present to management the key performance indicators related to quality process.
Work with R&D and Design Quality Engineers to support implementation of new products by reviewing quality and testing plans.
As assigned, maintain various Quality Systems such as CAPA, complaints, Non-conformance, supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
Develop, select, and test packaging materials for new products.
Improve packaging on existing products.
Design and supervise packaging testing.
Develop and implement product labels.
Develop and implement instructions for use.
Perform additional duties as assigned.
Degree in related field or equivalent.
A minimum of five (5) years of related experience.
Experience leading projects.
Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).
Knowledge of medical device labeling requirements and methods for implementation.
Problem solving skills with a Can do approach.
Strong written and verbal communication skills.
Knowledge of medical product manufacturing.
Command of ISO and FDA requirements for medical products : EN ISO 13485.
Ability to understand the technology related to MicroVention products.
Ability to read and prepare technical documentation.
Experience developing and executing related protocols.
Computer skills including MS Word, Excel, and CAD.