Job Description
POSITION SUMMARY
Manages the receipt of client instrument sets and medical devices. Inspects implants, devices and instruments for delivery acceptance and reports any non-conformance. Picks instrument sets and/or devices and prepares for shipment to clients; records and replaces consumed medical devices. Keeps records of product movement, inventory, inspection results and dispositions of inventory.
ESSENTIAL JOB FUNCTIONS:
1. Follows defined Standard Operating Procedures (SOP), Work Instruction (WI), drawings, and specifications.
2. Receives loaner sets into client's and Owens & Minor's inventory/tracking systems.
3. Opens and inspects medical devices / instruments.
4. Documents non-acceptable inspection results; escalates to client's Quality Assurance representative and O&M Regulatory & Compliance for remediation.
5. Replaces required medical devices as required.
6. Closes and records completed instrument set or kit in client's and Owens & Minor's inventory/tracking systems.
7. Picks and prepares sets and/or devices for shipping as directed.
8. Performs and records all other relevant tracking/inventory tasks.
9. Maintains records of inspection results and dispositions.
10. Maintains current versions of SOPs, WIs, drawings, and specifications related to all inspection activities.
11. Monitors instrument device calibration schedule to ensure maintenance frequency and measurement accuracy.
12. Maintains operational suitability of inspection and designated quarantine areas.
13. Creates daily, weekly, monthly inspection metrics.
14. Ensures products distributed and stored adhere to Quality System policies, procedures, and with client and regulatory requirements.
15. Maintains current documentation used for inspection activities.
16. Properly handles any non-conforming product; ensures compliance to Calibration system; reports any issues/defects to Branch Operations Supervisor.
SUPPLEMENTAL JOB FUNCTIONS:
1. Performs additional duties as directed.
Qualifications
EDUCATION & EXPERIENCE REQUIRED:
- High School diploma or GED required
- Surgical Instrument Technician certification strongly preferred
- At least one year of experience conducting surgical instrument inspections, or working with reusable medical devices is preferred
- Experience working in an International Organization for Standardization (ISO), Federal Drug Administration (FDA), or Current Good Manufacturing Practice (cGMP) regulated environment preferred
KNOWLEDGE SKILLS & ABILITIES:
- Experience working in hospital central sterile department, or working with Surgical instruments is preferred
- Demonstrated history of thorough work with strong attention to detail
- Good documentation skills
- Solid communications skills, both oral and written
- Proficient with Microsoft software (i.e., MS-Word, MS-Excel, MS-Outlook)
- Proficient with Pilgrim software (e.g., SmartDoc, SmartCAPA, etc.) a plus
- Proficient with Red Prairie software a plus
ADDITIONAL REQUIREMENTS:
1. Ability to work overtime as required
Note: Owens & Minor is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at our Company via email, the Internet, or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of our Company. No fee will be paid in the event the candidate is hired by our Company as a result of the referral or through other means.