Quality Technician (Medical Device - ISO 13485)

Job Description

Job Description

SUMMARY / OBJECTIVE

To be the premier choice in the medical custom sewn products market, it will be important to learn and understand our business, treat people more important than things and promote growth and development to achieve a standard of excellence. By planning ahead and involving others in decisions that affect every individual in our company, we believe our communication will be effective. Through problem solving, innovative ideas, and the steadfast belief in quality over quantity, we will be the premier choice in our field.

This Job Description describes the duties, responsibilities, and expectations for the position of Quality Technician for TPI.

ESSENTIAL FUNCTIONS AND PRIMARY RESPONSIBILITIES – Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The basic function of the Quality Technician is to perform all actions related to product conformance and verification to customer specifications per TPI documented procedures and Quality Management System.

· Maintain TPI's approved Pre-production sample inventory.

· Perform accurate incoming receiving inspection of supplied products and services.

· Perform 1st Article inspections and verification per customer supplied production samples as required.

· Perform in-process and final inspections.

· Manage and review non-conforming product and associated records.

· Perform and report the results of regular safety audits.

· Ensure work and results are documented per TPI's QMS.

· Lead corrective and/or preventive action management, including identifying opportunities, root cause, and proposing an effective solution and/or improvement.

· Cross-departmental collaboration to ensure quality throughout the product's lifecycle.

· Perform training of team members, as required.

· Must perform to the best of their ability all other tasks assigned by Management.

· Supply input to Management regarding employee performance for job performance reviews.

SECONDARY RESPONSIBILITIES

Perform miscellaneous projects and complete various tasks as requested by management.

JOB SPECIFICATIONS

Education, Experience and Credentials

· A High School Diploma or equivalent is required.

· 2-5 years' experience in manufacturing ISO 13485.

· Experience with Microsoft Office Suite is required.

· Experience with analytics and databases is preferred.

Knowledge, Skills, and Abilities

· Must be able to address and overcome all issues related to the accurate posting and recording of data for all department related work.

· Must document records per TPI's QMS and ISO documentation requirements.

· Must lead by example in all areas affecting product quality showing professionalism and unbiased input towards TPI's commitment to Quality.

· Must possess statistical and analytical skills and be able to apply math skills as required.

· Must be able to possess the ability to coordinate or direct quality inspectors with a variety of routine projects and activities simultaneously without losing focus and professionalism and be able to complete assignments in a timely fashion.

· Must work safely in production environment with minimal direct supervision.

· Must have excellent hand-eye coordination and have good color acuity and excellent vision.

· Must be able to execute TPI's core values.

PHYSICAL REQUIREMENTS NECESSARY TO PERFORM THIS JOB

· Must be able to walk around the production area, navigating around production equipment and materials.

· Must be able to sit, stand and work at a production table for extended periods of time.

· Must have excellent eyesight and hearing, with or without correction.