Quality Coordinator

Nissha Medical Technologies•Colorado Springs, CO

3d•Onsite

About The Position

The Quality Coordinator is responsible for ensuring the quality and conformance of manufactured products and assemblies at Nissha Medical Technologies by performing the essential functions listed below. Additional responsibilities include coordinating outside service activities and maintaining records of calibration, environmental monitoring, and customer-required testing results.

Requirements

High School Diploma or General Education Degree (GED)
Minimum 3 years of experience in a manufacturing environment and/or quality control role.
Knowledge of QMS principles, concepts, systems, industry practices, and standards.
Highly organized, detail oriented, and works effectively as both a team member and independent contributor.
Demonstrated proficiency in MS Suite, particularly in Microsoft Word and Excel.
Ability to work independently with minimal supervision.
Ability to clearly communicate (oral & written) and work well with employees at all levels.
Acts with sound and proactive judgement, seeking clarification as appropriate to minimize/eliminate delays.
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 apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.

Nice To Haves

Working knowledge of basic metrology and using measurement tools and equipment preferred.
Proficiency using scheduling programs/databases preferred.

Responsibilities

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 or regulations are met.
Demonstrate knowledge and acts in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
Abide by all safety and security rules set forth by the company and regulatory agencies.
Complete incoming Receiving Inspections as time allows.
Responsible for final audit of product after all manufacturing and testing has been performed per the MAI and applicable work instructions.
Assist with basic dimensional inspections as needed.
Ensure that product that does not conform to specifications is prevented from being used or delivered.
Communicate with Quality Inspectors, Quality Technicians, Engineers and all stakeholders for correcting and/or dispositioning of nonconforming products.
Maintain appropriate records to complete the evidence of conformance, specifically on the job sheet.
Help gather necessary product release documents per customer requirements for device shipment.
Create the Certificate of Conformance for the device shipment.
Act as EAM Administrator for all devices and equipment at Nissha Medical Technologies.
Maintain records of calibration.
Ensure Preventive Maintenance work requests are completed and closed.
Review, approve, and implement EAM Asset Requests.
Install equipment at appropriate locations throughout the facilities.
Ensure equipment is properly maintained, labeled, and stored in established locations.
Manage the calibration and PM schedules for all equipment in EAM and ensure all equipment is properly calibrated, labeled, and controlled.
Remove from service equipment that is damaged or no longer in use.
Coordinate calibration with established outside services when equipment is due.
Initiate nonconformance investigations for equipment found damaged or out of calibration.
Coordinate quarterly environmental monitoring with approved agency.
Coordinate annual particulate testing of for certified cleanrooms with approved agency.
Coordinate bioburden and LAL testing of products and components with approved agency.
Coordinate sterilization services as required by the customer with approved agency.
Maintain records per established procedures.
Responsible for performing and documenting in-process audits in production areas.