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Quality Coordinator I

Summary

**Title:** Quality Coordinator I

**ID:** 2874

**Department:** Quality

**Location:** Colorado Springs, CO

Description

Nissha Medical Technologies is looking for a Quality Coordinator I to join our Qulity Team in Colorado Springs!

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.

The established Compensation for this position will be $20.00-$26.00 per hour based on qualifications and experience (paid on a weekly basis).

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

General:

+ 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.

+ Demonstrates knowledge and acts in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.

+ Abides by all safety and security rules set forth by the company and regulatory agencies

+ Regular attendance is required.

+ Other duties as assigned.

Final Product Audit:

+ Responsible for final audit of product after all manufacturing and testing has been performed per the MAI and applicable work instructions.

+ Assists with basic dimensional inspections as needed.

+ Ensures 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.

+ Maintains appropriate records to complete the evidence of conformance, specifically on the job sheet.

+ Helps gathers necessary product release documents per customer requirements for device shipment.

+ Creates the Certificate of Conformance for the device shipment.

Equipment Calibration:

+ Act as EAM Administrator for all devices and equipment at Nissha Medical Technologies.

+ Maintain records of calibration.

+ Ensures 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.

Outside Services and Testing:

+ 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.

+ Maintains records per established procedures.

Audits:

+ Responsible for performing and documenting in-process audits in production areas.

REQUIREMENTS:

+ High School Graduate or equivalent (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.

+ Working knowledge of basic metrology and using measurement tools and equipment preferred.

+ 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.

+ Proficiency using scheduling programs/databases preferred.

+ 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.

Great benefits available including Medical, Dental, Vision, 401k, Short-Term Disability, Long-Term Disability, Basic and Voluntary Life Insurance, Paid Vacation Time, Paid Sick Leave, Educational Assistance, and more!

_Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression,national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities._

_If you need assistance with completing the online application process, please call (719) 426-9074._