Quality Inspector II

Nissha Medical Technologies•Colorado Springs, CO

38d•Onsite

About The Position

The Quality Inspector II is responsible for verifying incoming raw materials, in-process, and final product to ensure that materials that do not conform to specification are prevented from being used or delivered. Maintains appropriate records to complete the evidence of conformance and performs the following essential functions and basic duties: Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and regulations are met. Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual. Inspection of components and documentation for purchased product. Inspect product using standard inspection gages such as micrometers and vernier/calipers, optical comparators, and visual coordinate measurement systems. Inspection of product using visual standards. Testing of product using tensile testing equipment. Use of good documentation practices (GDP) of inspection results for presentation to Material Review Board and inspection history files. Generate Quality Material Reports (QMR) to document discrepant materials. Process dispositioned material after inspection and/or MRB activities. Maintain accurate Inspection Record files. Interact with all levels of company team members. Perform In-Process and Final Inspections where applicable. Gather sterilization and other external records for inclusion into the Device History Record (DHR). Provide lot release documentation to customers as required. Review and approve the final DHR packet authorizing release of product. Assist with production re-inspection activities as needed. Support internal/external audits by providing evidence as requested. May be required to work overtime when necessary. Other duties or special projects may be assigned as requested. Abides by all safety and security rules set forth by the company and regulatory agencies Regular attendance is required.

Requirements

High School Diploma or General Education Degree (GED)
Minimum 2 years of related experience
Demonstrated proficiency in MD Suite, particularly Microsoft (MS) Word and Excel.
Knowledge of GD&T
Ability to read and interpret drawings/specifications.
Familiarity with standard inspection tools to include calipers, micrometers, optical comparator, scales, and pin gauges.
Must be highly organized, detail oriented, and work effectively as both a team member and independent contributor.
Strong written and oral communication skills.
Ability to read and interpret documents such as safety rules, operating and Maintenance instructions and procedure manuals.
Ability to write routine reports and correspondence.
Ability to deal with problems involving several concrete variables in standardized situations.
Well-developed verbal, numerical reasoning, and analysis skills with ability to draw sound conclusions.

Nice To Haves

Medical Device experience preferred.
Previous experience designing fixtures or tooling is preferred.
Vision System and CMM operation experience preferred.
ASQ CQI preferred.

Responsibilities

Verify incoming raw materials, in-process, and final product to ensure conformance to specifications.
Prevent non-conforming materials from being used or delivered.
Maintain appropriate records to complete evidence of conformance.
Follow Employee guidelines and Quality System Regulations.
Inspect components and documentation for purchased product.
Inspect product using standard inspection gages such as micrometers, vernier/calipers, optical comparators, and visual coordinate measurement systems.
Inspect product using visual standards.
Test product using tensile testing equipment.
Utilize good documentation practices (GDP) for inspection results.
Generate Quality Material Reports (QMR) to document discrepant materials.
Process dispositioned material after inspection and/or MRB activities.
Maintain accurate Inspection Record files.
Interact with all levels of company team members.
Perform In-Process and Final Inspections.
Gather sterilization and other external records for inclusion into the Device History Record (DHR).
Provide lot release documentation to customers as required.
Review and approve the final DHR packet authorizing release of product.
Assist with production re-inspection activities.
Support internal/external audits by providing evidence.
Work overtime when necessary.
Perform other duties or special projects as assigned.
Abide by all safety and security rules.
Maintain regular attendance.