Owens & Minor Instrument Set Technician in Hanover, Maryland
Manages the receipt of client instrument sets and medical devices.Inspects implants, devicesand 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.
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 InternationalOrganization 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
1.Ability to work overtime as required