Job Summary
Responsible to coordinate, and or calibrate, and maintain Inspection Measuring and Test Equipment (IM&TE) to demonstrate the conformance of equipment to specified requirements at the operations level across the Current Good Manufacturing Practices (cGMP). The Calibration and Preventative Maintenance Coordinator will ensure safe practices are followed and will escalate whenever they are uncertain. The coordinator will use a variety of tools and test methods and adhere to properly released work instructions and Quality System procedures, proper material handling, ESD procedures, and more. Responsible for following good documentation practices (GDP) and performing all required electronic systems transactions accurately and in real time.
Responsibilities:
Organize and supervise calibration events for test equipment across Facilities at regular intervals.
Be proficient in the use of the calibration and maintenance database (data entry, record maintenance and report generation).
Help develop and maintain written calibration and preventive maintenance procedures and work instructions.
Inspect conditions of calibrated measurement and specifications; carry out uncomplicated repairs; and supervise the repair of difficult technical problems by the best hands available to prevent continuous break down of equipment, which can result in low quality production. Nonconforming equipment will follow the nonconforming process. Customer owner equipment requires their approval for calibration and repairs.
Report discrepancies as required when inspection, measuring and test equipment performance results are unsatisfactory. Calibration failures and equipment failures require risk analysis documented on NCR.
Perform environmental monitoring activities according to established procedures.
Procure and order spares from vendors for test equipment and supplies for the test lab.
Perform maintenance on a variety of test equipment, suggest and implement improvements.
Maintain the Calibration Lab to 6S standards. Maintains the work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
Follow all company safety policies and other safety precautions within the lab/shop/manufacturing area.
Attend required safety training. Promote safety to all associates that enter the work area.
Understands and follows good documentation practices in a cGMP and ISO 13485 environment.
Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO 13485 requirements.
Maintains manufacturing documentation as outlined in the work order package and defined by the customer.
Identifies and reports any product quality problems or discrepancies.
Documents non-conformances.
May perform other duties and responsibilities as assigned.
Essential Requirements
Positive attitude, self-motivator, tenacious follow up, and superior organization skills.
Superior customer service attitude.
Excellent teamwork, communication and interpersonal skills.
Minimum High School Diploma or Equivalent. Associate’s degree or technical certificate in calibration instrumentation and process control technology Preferred. Previous work experience in medical device manufacturing a plus.
Requires 1-2 years’ experience in technical industrial manufacturing or laboratory/controlled environment preferred.
Working knowledge of GMP / ISO requirements for documentation.
Possession of advanced professional knowledge of calibration practices.
Interpersonal skills with a focus on customer service (internal).
Good communication (written and verbal) skills.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to operate a personal computer including using a Windows based operating system and related software.
Computer knowledge and proficiency.
Personal computer literate with skills in word processing, spreadsheets, and EES developed systems.
Ability to read and comprehend simple instructions, short correspondence, and memos.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent and to draw and interpret graphs.
Additional skills but not required: experience in ERP, PLM and QMS software and Enterprise Asset Management Solution (EAM) software, managing databases.
A demonstrated commitment to company values.
Excellent manual dexterity and eye/hand coordination.
Standing for prolonged periods of time.
Sitting for prolonged periods of time.
Ability to lift up to 30 lbs.
Columbia Tech is an Equal Opportunity Employer. Columbia Tech does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.