Job Details

ID #40033022
State Oregon
City Gresham
Job type Full Time
Salary USD TBD TBD
Source Orchid Orthopedics
Showed 2022-05-01
Date 2022-04-30
Deadline 2022-06-29
Category Et cetera
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Quality Management Systems Coordinator

Oregon, Gresham, 97080 Gresham USA

Vacancy expired!

SUMMARY OF POSITIONThe Coordinator, Quality Management Systems is responsible for ensuring compliance of the Quality Management System (QMS) for Orchid Oregon. This includes developing training in conjunction with internal subject matter experts, validation of the QMS, ongoing technical support and training, and identifying continuous improvement opportunities. This position will be responsible for assisting with Customer/Internal Audits, Document Control, Supplier Quality Management, Quality Management Review and NCR/CAPA/RMA management.

The Coordinator, Quality Management Systems will report to the Senior Manager, Quality Orchid Oregon.

SHIFTORE - Shift 1 ($0) (United States of America - Oregon)

WHAT YOU WILL DO
  • Lead quality and compliance by utilizing One Orchid global processes and complying with all Quality Management Systems (QMS) documentation requirements and establishing/supporting plan(s) to meet/exceed Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.
  • Maintains the Quality Management System (QMS) and ensures training is performed and recorded as required and serves as a backup resource and matters of quality and regulatory compliance
  • Acts as site administrator for the QMS
  • Ensures documents in the QMS are up to date and reviewed at regular intervals
  • Collaborates with Orchid sites to establish QMS best practices and continuous improvement
  • Processes and reviews document creation/change requests
  • Assists document owners with writing, editing and training of new and revised procedures
  • Assists with setting up, tracking and recording training events
  • Verifies employee training is current and complete
  • Provides QMS training to employees
  • Assists with customer audits
  • Assists with NCR, CAPA, RMA, and audit findings
  • Handles customer rejections and returns and logs into customer return database
  • Develop and maintain supplier documentation files
  • Assist with recording management review meeting minutes and tracking management review actions
  • Performs other work as assigned

WHAT WE ARE LOOKING FOR

WORK EXPERIENCEExperience creating or modifying controlled documents (Required), Experience in quality-related work (Required), Experience with FDA and ISO systems relating to medical devices (Preferred), Experience with Structured Query Language (SQL) and SQL Server Reporting Services (SSRS) (Preferred)

EDUCATIONAssociates, , , High School Or Equivalent Required

CERTIFICATIONSNone - -

KNOWLEDGE & SKILLS THAT ENABLE SUCCESSAccuracy and Attention to Detail (Working Experience), Collaboration (Working Experience), Computer Knowledge (Working Experience), Decision Making and Critical Thinking (Working Experience), ISO 13485 (Basic Knowledge), Organization (Basic Knowledge), Quality Management (Basic Knowledge), Web-Based Tools Management (Working Experience)

WHAT WE OFFER
  • Opportunity to work in a growing company
  • Ability to help people live a longer, more active life
  • Comprehensive benefit package
  • Ability to work in an organization that values:
    • Integrity First: We do the right thing
    • Teamwork: We are one Orchid
    • Results: Our results matter

PHYSICAL REQUIREMENTS

  • Frequent and repetitive use of hands and fingers
  • Lifting, pushing, and pulling of up to 30 lbs.
  • Requires sitting for extended periods of time.
  • Wear safety glasses on production areas
  • Required: walk, stand, bend, stretch, squat, stoop, reach, speak, and hear
  • Able to work in a fast-paced, stressful, quality oriented environment

ADDITIONAL REQUIREMENTS
  • Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
  • Candidates must be able to provide proof of eligibility to work in the United States through eVerify

EOE, including disability/vets

Vacancy expired!

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