Essential Duties and Responsibilities include the following (other duties may be assigned):
Assess the condition of product, from its raw material stage to being a completed product, throughout the manufacturing process to ensure it is not damaged or have any defects.
Provide support to operations during manufacturing regarding paperwork, documentation, calibration, etc.
Provide clean room support during manufacturing builds, including, but not limited to, participation in area clearance and line clearance, documentation oversight (as required), confirmation of manufacturing documentation information (as required), reconciliation.
Conduct Quality review of product labeling including barcodes, lot numbers and WIP labels.
Reconcile manufacturing documents (batch records) with finished parts inventory; perform documentation reviews of Device History records, inspection and test results.
Monitorproduct quality (including inspection if required)
Assess customer complaint information as it pertains to manufacturing documentation
Confirm maintenance and calibration of equipment (i.e. gauges, balances, etc.) used for manufacturing is current or removed from service prior to the due date.
Collectdata (manufacturing data and yields, testing, production, etc.)
Performfailure and routine analysis
Auditmaterials, processes and documentation
Check for regulatory compliance
Complete administrative functions.
Support QA Receiving Inspection functions for incoming raw materials and finished goods.
Perform visual, dimensional, and functional inspection of product and components per procedure, specification or drawings using measuring equipment (i.e. caliper, micrometer, tape, height gauge, etc.)
Support the Returned Goods Authorization (RGA) process as needed to maintain continuous flow and increase inventory accuracy.
Mine data for calculation/analysis/interpretation by others.
Participate in annual hazardous waste training
Assist in the investigation and resolution of Non-Conforming materials and product related issues.
Support activities of the Quality Review Board (QRB) as necessary.
Provide administrative / technical support to the Quality Assurance department in the performance of investigations on reported product failures, adverse events or field complaints in accordance with FDA, MDD, and ISO 13485 requirements.
Update and create Standard Operating Procedures for Quality System related activities.
Perform other related tasks as assigned.
Education and Experience:
Minimum Associate's degree (AA) or equivalent from two year college or an equivalent combination of education and experience and 5+ years of Quality Control and Quality Assurance experience in the medical device or pharmaceutical / biotech industry, with working knowledge of FDA and ISO regulations.
Must have clean room experience and production manufacturing experience.
ASQ CQT certification a plus.
Other Skills and Abilities:
Knowledge of ISO, FDA and Quality System Management concepts and guidelines
Strong organizational, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
Must be able to work under minimum supervision and in a team environment.
Ability to read, analyze, and interpret technical procedures and regulations.
Ability to work with mathematical problems such as adding, subtracting, multiplying, dividing, decimals and math conversions. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to lift heavy items (35 lbs.).
Ability to utilize multiple word-processing, and database applications including MS Office applications, Word, Excel, Access, as well as Adobe Acrobat, etc.
COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s).
Micell Technologies is an innovative technology company dedicated to transforming medical devices for improved patient outcomes. The Company’s supercritical fluid technology is a key component in its enhanced drug delivery system, which is currently in use within the interventional cardiology market, though the technology has potentially far-reaching applications for treating cardiovascular diseas...e. Focused on eliminating some of the primary limitations typical of existing technologies used to create drug-eluting medical devices, Micell is committed to bringing this unique approach to market.