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Quality Assurance Technician in Louisville, KY at Owens & Minor, Inc.

Date Posted: 5/7/2019

Job Snapshot

Job Description

JOB SUMMARY:

 

Manage the receipt of client product, Inspect medical devices / instruments for acceptance and report any non-conformance to Regulatory, record and replace consumed medical devices, pick and prepare for shipment.  Perform record-keeping activities of product movement, inventory, as well as inspection results and dispositions. 

Assist in handling non-conforming Quality Control issues that impact the 3PL business unit, including federal, state, and local regulatory issues, training and development, product compliance, special handling regulations, and related information technology requirements.

Maintain current documentation used for inspection activities.  Ensure compliance to Calibration system. Reports to Director, Regulatory & Compliance.



ESSENTIAL JOB FUNCTIONS:

1.   Ensure facility Quality Systems are maintained in compliance with cGMP, ISO9001 2008, ISO 13485, and 21 CFR part 11, part 7- subpart C (Recalls), and part 820 (Quality System Regulation).

2.   Ensure products distributed and stored adhere to Quality System policies, procedures, and with client and Regulatory requirements.

3.   Perform the following tasks as defined by SOPs, WIs, drawings, and specifications:

    1. Access client system for daily task direction
    2. Receive loaner sets into both client and O&M systems.
    3. Open and Inspect medical devices / instruments (i.e., Receiving, In-Process, Finished Product).
    4. Escalate non-acceptable inspection results to Director, Regulatory & Compliance, for remediation.
    5. Replace required medical devices as required.
    6. Close and record completed set in both client and O&M systems
    7. Pick and prepare sets for shipping destination as directed by client system
    8. Perform and record all other relevant tasks.
    9. Maintain current versions of SOPs, WIs, drawings, and specifications related to all inspection activities.
    10. Maintain records of inspection results and dispositions.
    11. Monitor instrument device calibration schedule to ensure maintenance frequency and measurement accuracy.

  1. Participate, when assigned, in the following activities:

A.   CAPAs, Internal Audits, or external supplier audit

B.   Drafting SOPs, WIs, and forms for uploading into SmartDoc

C.   Investigation and resolution of non- conforming products

D.   Product training

  1. Establish and maintain operational suitability of inspection and designated quarantine areas.

  1. Create monthly inspection metrics.

 

 

SUPPLEMENTAL JOB FUNCTIONS:

          Perform additional duties as assigned.



QUALIFICATIONS:

 

          EDUCATION & FORMAL TRAINING:

 

                   High School or GED required; Bachelor's Degree preferred.

 

          WORK EXPERIENCE:

 

At least 2-4 years of experience conducting mechanical / technical inspections.  Experience with reusable medical devices and stainless steel processing experience a plus.

KNOWLEDGE, SKILLS, & ABILITIES:

 

A.   Working knowledge of regulations (ISO, FDA (210,211, 820), standards, current industry practices, and cGMP regulated environment.

B.   Able to read and interpret blueprints, SOPs, and WIs.

C.   Proficient with common inspection instruments and tools to appraise product.

D.   Healthcare industry experience a plus.

E.   Third party logistics experience is strongly preferred.

F.    International regulatory experience / exposure a plus.

G.   Excellent verbal communication, presentation, and facilitation skills.

H.   Problem solving skills.

I.     Flexibility with an ability to lead and work as part of a team.

J.    Customer first focus.

K.   Outstanding communications skills - both oral and written.



EQUIPMENT, TOOLS AND WORK AIDS:

1.   Proficient with Microsoft software (i.e., MS-Word, MS-Excel, MS-Outlook) required

2.   Proficient with Pilgrim software (e.g., SmartDoc, SmartCAPA, etc.) a plus

3.   Proficient with Red Prairie software a plus

4.   Knowledgeable of general office equipment, to include PC

WORKING CONDITIONS AND ENVIRONMENTAL HAZARDS:

1.   Inside working conditions.

2.   No environmental hazards indicated for this classification.

 

 

STRENGTH REQUIREMENT:

Sedentary Work: Exerting up to 50 pounds of force occasionally and / or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves walking and standing most of the time, but may involve sitting for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

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