Quality Inspector - 1St Shift

Paragon Medical serves as a strategic partner in medical device manufacturing, offering an end-to-end supply chain solution from initial concept and product development, to verification and validation testing, to final production, assembly, and ongoing strategic demand planning. Our experts have deep experience across a wide range of applications including implants, surgical instrumentation, single-use disposable devices, and many more. We produce everything from high-precision individual components and assemblies to complete end products. Our differentiated and personalized solutions are designed to exceed customer expectations every time.
SUMMARY OF POSITION: Responsible to support the manufacture of surgical instruments, implantable components or cases and trays. Responsible to perform receiving, in-process or final inspections.
ESSENTIAL FUNCTIONS:

• Responsible for utilizing aptitude in measurement techniques, metrology, and blueprint reading and verify operators are accurately measuring and recording dimensions on IP sheets or other documentation.
• May perform first article and first piece approval for operators.
• Perform inspection duties, as required.
• Perform new hire and on-going training to ensure requirements are met.
• Support quality improvement and cost savings initiatives, as required.
• Assist Quality Engineers, as required.
• Assist in other production areas, as needed.
• May perform other quality or document control duties, as assigned.
• Be able to meet the visual acuity requirements (shades of color and color blindness).
• Be able to meet the requirements of the vision screening test (eye chart).
• Once employee demonstrates competency in position, he/she may be required to train others in similar roles.

RESPONSIBILITIES FOR EMPLOYEES ASSIGNED TO A LEAD ROLE MAY INCLUDE:

• Complete, calculate and post the cell's data from the previous day.
• Assist in assuring "Ship Today" & "Priority" orders are moved through final as to their level of importance.
• Review all pending orders to resolve issues or contact the proper people for resolution.
• Monitor the Quality Hold return shelves in Final and assign the orders to the appropriate inspector for final review and resolution.
• Subject matter expert on the following: documents, certifications, cosmetics, measuring product, locating needed gages and correcting issues on IPs sheets and routers.
• Responsible for controlling final inspection gage cabinets and assuring gages are within their calibration time frame. Responsible for control of gage sign-out and tracking.
• Responsible for timely dispensing of scrap.
• 6S champion for Final Inspection. Maintain a neat and orderly workspace as well as the department in accordance with plant/departmental 6S standards, where applicable.
• Perform first piece approval for operators and ensure proper documentation.
• Assist in verifying production procedures have been followed and records are properly maintained.
• Assist in resolution and disposition of non-conforming materials found in inspections performed.
• Follow the production schedule ensuring team members know what inspections need to be completed during their shift.
• Identify gages, fixtures and special tools needed for production and ensure availability for production.
• Capture any improvement or changes on IP sheets and control plans and communicate to appropriate Quality Engineer or Quality Tech.
• Cover for Quality Cell Leader, as needed, in their absence.

EXPERIENCE / EDUCATION: High school diploma or equivalent. Post-secondary education a plus. Moderate to proficient knowledge of statistical analysis and methods required. Working knowledge of inspection methodology. Proficiency in blueprint reading and experience and knowledge of GD&T. A minimum of three years in a manufacturing environment. Previous quality experience required. Attainment or future attainment of an ASQ CQT certification preferred.
SKILLS: Good interpersonal skills and the ability to cultivate and maintain cooperation from others. The ability to use inspection equipment such as micrometers, calipers, gage blocks, and pin gages. Excellent organizational and record-keeping skills. Basic computer skills. Attention to detail required.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:The physical demands and work environment characteristics described here are representative of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical demands: While performing the duties of this job, the employee is occasionally required throughout the workday to stand; walk; sit; use hands to handle objects, tools, or controls; reach with hands and arms; balance; stoop, kneel, crouch; talk or hear. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to see print in various sizes and formats. May be required to climb stairs. Must regularly be able to pull and push up to 25 pounds and occasionally lift up to 50 pounds.
• Work environment: Work performed in a production environment. While performing the duties of this job, the employee is exposed to weather conditions prevalent at the time (for Maintenance & Receiving only). The noise level in the work environment is usually moderate to high, in some areas.

Paragon Medical is committed to maintaining an inclusive, safe, and respectful working environment for all employees, regardless of age, color, disability, ethnic background, gender, gender identity, national origin, race, religious belief, affectional or sexual orientation, marital status, veteran status, citizenship or impending citizenship, or any other characteristic protected by law. Employees should be able to work and learn in a safe yet stimulating atmosphere and Paragon Medical will not tolerate intimidating, hostile, abusive, or offensive behaviors in our workplace. Paragon does not condone such conduct, which will be considered harassment or inappropriate conduct and is strictly prohibited.