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Quality Control Inspector II

Confluent Medical Technologies INC Warwick, RI

  • Posted: over a month ago
  • Full-Time
Job Description
Summary

This position provides both QC inspection and Quality Systems support. Performs inspection and /or testing of manufactured medical grade material as required to certify quality and adherence to specifications. Uses basic inspection and measurement instruments. Records results of all testing procedures. Serves as the Warwick ETQ administrator and support for change control and documentation. Assists Warwick Quality Systems team to maintain and control quality assurance systems related to document control; document scanning and archiving; lab testing; and materials testing.   Communicate with Engineering and Operations on technical matters related to product documentation and training requirements.

 

 

Essential Duties and Responsibilities

Include, but not limited to, the following:

 

QC Inspection and Endotoxin Testing

  • Performs final inspection (diameter) of finished material per procedures to certify quality and adherence to specifications.
  • Performs in-process and final Endotoxin testing, as required, for products and material including textiles, water, and chemicals per procedures to certify quality and adherence to specifications.
  • Performs data entry, analysis, and trending of lab test results as required.
  • Records inspection and test results per procedures.
  • Reviews inspection results where required.
  • Position interacts with both operations and engineering departments and requires individual to be supportive, cooperative and an effective communicator. 
  • Complies with all Quality System policies and procedures.
  • Performs other tasks as assigned by Supervisor/Manager.
     
     

 

XRF Materials Testing

  • Performs XRF materials testing on submitted materials from all Confluent locations to assess REACH, ROHS, and Prop65 compliance.
  • Assure proper submittal forms are completed for materials to be tested.
  • Report results to Supervisor/Manager or designee. 
  • Train other associates on the XRF testing machine as required.

 

 

 

 

 

Quality Systems Support and duties

  • Provides daily support for Warwick site to maintain and control quality systems related to document control and training in ETQ. Ensures when required, customer approval is obtained and submitted with change requests.
  • Support Warwick team to maintain ERP system (Epicor) as it pertains to Doc Control, QSR and ISO requirements.
  • Coordinate and control that product and product process changes documented through the product/process change system are validated according to the established requirements per Design and Change Control systems.
  • Communicates Warwick training / sends training records to Warwick team leaders.
  • Maintain database and control of documents in satellite locations throughout the CE Rooms in the facility.
  • Review label information on production batch records prior to shipping, as required.
  • Filing and scanning of batch records and maintenance with off-site storage company (Iron Mountain).
  • Support appropriate parties during internal and external customer and regulatory audits, as required.

 

Supervisory Responsibilities

None

 

Supervision Received

General supervision: routine duties are performed with minimal supervision; standard practices or procedures allow proceeding alone at routine work; occasional check of work while in progress; work is reviewed upon completion.

 

Other Duties and Responsibilities
  • Comply with all safety policies, practices and procedures.  Report all unsafe activities to supervisor and/or Human Resources.
  • Participate in proactive team efforts to achieve departmental and company goals.
  • Provide leadership to others through example and sharing of knowledge/skill.
  • Perform other duties as assigned. Accomplishes all tasks as appropriately assigned or requested.
  • Must be reliable, and able to work overtime on short notice.
 Competency:

To perform the job successfully, an individual should demonstrate the following competencies:  

  • Problem Solving - Gathers and analyzes information skillfully.  
  • Interpersonal - Maintains confidentiality.  
  • Oral Communication - Listens and gets clarification.  
  • Written Communication - Varies writing style to meet needs.  
  • Attendance/Punctuality - Is consistently at work and on time.  
  • Dependability - Follows instructions, responds to management direction.  
  • Planning/Organizing - Organizes or schedules other people and their tasks.  
  • Professionalism - Treats others with respect and consideration regardless of their status or position.  
  • Quality - Monitors own work to ensure quality
  • Quantity - Works swiftly and efficiently
  • Microsoft Word and Excel
  • Pipetting technique and aseptic practices
 

 

 

Qualifications

 

Education and Experience
  • High school diploma; or two to five years related experience and/or training; or equivalent combination of education and experience. 
  • Experience with a medical device firm (or sub contractor) with clean room environment inspection preferred.
  • Experience with inspection, including measurement tools, interpreting engineering drawings preferred.
  • Knowledge of International Standards (ISO) and FDA Regulations for Medical Industry

 

Communication Skills

Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to other employees of the organization.

 

Mathematical Skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

 

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, or diagram form.

 

Computer Operations

Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheet, graphics, etc.

 Certificates, Licenses, RegistrationsNone  Environmental Working Conditions

Light physical activity performing non-strenuous daily activities of a productive/technical nature.  Moderate noise (examples: business office with computers and printers, light traffic)

 

Physical Demands

Manual dexterity: sufficient to reach/handle items, works with the fingers, and perceives attributes of objects and materials.

 

Vision Requirements: Close vision (clear vision at 20 inches or less), depth perception (three-dimensional vision, ability to judge distances and spatial relationships), ability to adjust focus (ability to adjust the eye to bring an object into sharp focus). 

 

Between 1/3 -2/3 of the time, position requires standing, walking, sitting, using hands and fingers to handle, or feel, and reaching with hands and arms.  May be required to occasionally lift up to 10 lbs.

Confluent Medical Technologies INC

Address

Warwick, RI
02886 USA

Industry

Manufacturing

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