Purpose
This position operates various Putnam Medical machines for the medical device industry as well as adheres to Good Manufacturing Processes (GMPs) including such processes as testing, quality and documenting to ensure product meets specified criteria contained in the work orders/specifications/etc. This position normally works in a clean room.
Duties and responsibilities
- Follows PMC’s work instructions to assemble devices according to precise specifications
- Completes work orders by performing automated or manual operations and ensures product is produced on time.
- Sets up/tear downs, operates, monitors, and cleans Putnam Medical’s machines and other auxiliary equipment including fixtures and tooling. Evaluates products/processes and makes necessary adjustments to process to optimize quality and output within the bounds of standard operating procedures.
- Performs line clearance activities to maintain product integrity.
- Hand unload, package product for the next step and label product as directed to ensure highest possible quality.
- Performs, inspects, and packages products by using and/or performing quality-based inspections using a variety of measurement equipment including, but not limited to: Magnification Equipment, Precision Measuring Tools, Tape Measure, Pin Gages, Laser Micrometers, Micrometers and Video Microscopes.
- Documentation is legible, original and accurate following Good Documentation Practices. This includes both written and data entry.
- Verifies calibration dates on equipment before beginning work.
- May be cross trained as required to support business requirements
Quality:
- May be trained to perform some quality inspections/checks per the quality control plan/specification/work order and escalates issues to Quality Supervision and Leadership, when required.
- Adheres to all housekeeping standards and ensures workspace is clean, safe, and in working order within assigned area/s, as well as, to prevent product contamination. Clean all workspaces with Isopropyl alcohol and a lint-free clean room wipe prior to starting production.
- Attention to detail, must be able to complete multiple as well as repetitive tasks, must be committed to accuracy and quality.
- Ensure that all equipment, fixtures, and measurement devices used are within their calibration dates.
- Ensure that only the approved equipment and tooling listed within documents have been setup to produce the finished product per the associated Quality Plan.
- Review the work order packet for any additional required information (Lot #, Order quantity, etc.).
- Follows current Good Documentation Practices (GDP).
Safety:
- Works in a safety conscious manner. Ensures equipment is in working order.
- Adheres to safety requirements/practices/procedures as required, including required PPE/Clothing.
- Respect and follow workplace safety rules including, but not limited to, proper handling practices of chemicals per procedures, maintaining safe work practices, follow LOTO and HAZMAT polices, refer to SDS when applicable, and apply information found to the task at hand.
- Informs Supervision of injuries immediately. Completes Workers Compensation Employee Form at time of occurrence/s with Supervision.
General:
- Works with, and trains new or transfer employees, sharing knowledge and expertise. Provides coaching and/or training to co-workers cross training. When applicable.
- Regular and predictable “physical presence” on-site attendance is an essential job function and a prerequisite to perform other functions of the job.
- Performs other duties as required but in accordance with The Americans with Disabilities Act.
- Deales with conflicts in a constructive manner.
- Follows dress code and cleanliness requirements in order to prevent product contamination
Qualifications
Required Qualifications:
- High School Diploma, GED or equivalent work experience.
- Ability to read/write/understand English. Ability to read, write, and interpret all Putnam Medical’s documents including safety rules, operational instructions, procedure manuals, and SDS sheets.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals as well as measure in English and metric measurements.
- Mechanical aptitude to operate and troubleshoot machinery.
- Able to perform several tasks concurrently.
- Displays respect and sensitivity for all people regardless of age, color, gender, gender identity or expression, genetic information, national origin, pregnancy, race, religion, sexual orientation, protected veteran status, or because they are an individual with a disability or disabled veteran.
- Able to work well with others. Willing to assist others with their duties when needed to do so. Willingness to ask and answer questions. Listens to others with an open mind to differing opinions and ideas. Handles rapidly changing situations in a professional manner. Balances team and individual responsibilities. Contributes to a positive “team” spirit. Self-confident and motivated.
Preferred Qualifications:
- Previous experience with ISO 13485, US FDA regulations, or other quality systems.
- Ability to read prints and specifications.
- Some experience with plastics, medical device, aerospace, or pharmaceutical manufacturing.
- Mechanical aptitude to operate and troubleshoot machinery.
Working conditions
(With or without the aid of mechanical) The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Regularly required to stand, sit, walk, use hands to input, handle or feel, use of arms to reach, able to hear and talk.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
- Position requires some data entry and regular use of computer/keyboard/mouse.
- Required to stand for majority of an 8-hour work shift and lift/push/pull up to 50lbs repeatedly throughout work shift. Prolonged periods standing and walking throughout facilities.
- Works on a manufacturing floor. Periodically overtime could be required including weekends.