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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Director, Quality Assurance and Regulatory Affairs

This person will plan and manage all aspects of quality assurance and regulatory affairs of the company including implementation of quality assurance methods and regulatory procedures to ensure product reliability and conformance to process, inspection, customer specifications, government, licensing, and standards organizations.  They will provide overall corporate direction of all quality and regulatory activities, direct management, technical and operations employees engaged in quality and regulatory activities, and play an active role in the Total Quality and other similar processes of the organization.  This person will cooperate with other top management personnel in formulating and establishing company policies, operating procedures and goals.  They will also communicate the company policy, procedures and goals to customers, potential customers, vendors, and other stakeholders.  This person will develop positive relationships with Quality and Regulatory counterparts in customer and vendor organizations, develop initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures within the program.  They will review technical problems and procedures of departments and recommend solutions or changes.  They will visit and confer with representatives of material and component vendors to obtain information related to supply, quality, and capacity of vendor to meet orders, and vendor quality standards.  This person will participate with engineers about quality assurance of new and existing products and processes to ensure these are designed for quality and reliability and to ensure customer satisfaction and regulatory compliance.  This person will also improve product quality through proactive internal and external inspection of raw materials, finished items purchased, and production operations and processes.  They will ensure the Corrective and Preventive Action system is properly maintained and operating effectively, interpret quality and regulatory philosophy to key personnel, review all data obtained during quality and regulatory activities to ensure consistency with company policies and procedures.  This person will develop new approaches to solve problems identified during quality and regulatory activities.  They will keep management abreast of significant issues or developments identified through quality and regulatory activities, and prepare and present technical and program information to management team.

Bachelor's degree from four year college or university; and 8 years related experience and/or training; or equivalent combination of education and experience.  Must have at least 5 years experience and comprehensive knowledge of medical device industry, GMP, ISO-13485, Quality System Requirements, and Quality methods and processes.

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