Molding and Manufacturing Technician - 1st Shift

This person will be responsible for establishing, troubleshooting, repair and improvement of injection molding and manufacturing processes.  They will interact with engineering to establish injection molding processes for manfacturing including working with manufacturing and engineering on creation and execution of process validation activities.  They will perform all necessary tests, record results and examine product for form and texture to identify defects or imperfections as well as analyze and interpret test data.  They will also provide feedback and pro-active communication to supervisors, management and coworkers to ensure efficient operations.  Contributions are based on industry experience and hand-on knowledge of molding processes, mechanical and/or electrical systems, and components.  This person will troubleshoot and solve problems with routine manufacturing processes and equipment, documenting activities according to GMP and other regulatory requirements.  They will also study production processes and make recommendations for improvements or changes to standards and manufacturing procedure specifications.  They will assist manufacturing, engineering, and project engineering in identifying, specifying, and ensuring new equipment, specifically custom automation equipment, conforms to internal requirements, limitations and specifications for service utilities, software, mechanical or other attributes.   They will also participate in project planning meetings and design reviews, and recommend possible solutions.

Associate's degree or equivalent from two year college or technical school and five to ten years experience in an injection molding environment is required.  Ability to operate standard lathe, milling machine and other tool making equipment for fast turn-around of simple to moderately complex tooling and fixturing is required.

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Quality Assurance Administrator

The person performs the administrative functions of the Quality Management System.  They administer the quarantine, supplier corrective action and non-conforming material process for the company.  They will compile device history files for all product lines, review device history files for accuracy and completeness and prepare documentation for product release.  They also will issue supplier corrective actions to suppliers and follow up as appropriate.  They will perform QA inspections on finished goods and incoming materials as needed to support the department.  They will also perform other quality control inspections and observations under the direction of appropriate management and engineering personnel.  They will assist in hands-on training to fellow employees on operations and assist in external audits by regulatory agencies, certifying bodies or customers as well as assist in indexing, maintenance, storage and retrieval of device history records.  They will also collect QS data and report results in summary statistic format as well as initiate, review or collaborate on new or revised QS documentation.  Other responsibilities as assigned by supervisor.

Minimum of high school education is required in addition to two to five years of experience in QA and RA in the medical device industry.  Person must have good verbal and communication skills and be detailed oriented.

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