JOB SUMMARY:

Under minimal supervision, responsible for all Quality projects, compliance with Medline SOP’s, and product integrity issues for assigned distribution center. Investigate held finished goods which may result in inspections, reporting, and appropriate documentation. Manage holds and releases and completes rework assignments.

MAJOR RESPONSIBILITIES:

• Prioritize, coordinate, and perform all recall stock checks and reworks, providing expedited communication and completed reports to Recall Department
• Complete hold and release of products as advised.
• Prioritize and perform stock checks, including AQL specified inspection parameters when included, and report results via designated forms to divisional partners.
• Prioritize and perform deviations and reworks and provide detailed reports to divisional partners
• Coordinate project/rework area, required supplies, and labor resources including Operations and Temporary labor services.
• Maintain daily report of all held stock using SAP, Excel, and K2.
• Communicate with divisional partners to resolve hold issues and complete releases as authorized.
• Ensure distribution center compliance with Medline SOP’s and State and Federal regulations using monthly reporting tools; communicate with distribution center management to advise, plan, and implement corrections for non-conformances.
• Operate material handling equipment as necessary to complete held stock tagging, pull and replace products for reworks, stock checks, and inspections.
• Use computer systems daily for regular communication, generating and contributing to reports, investigating product related information, and tracking all project time.
• Recommend new or enhanced methods, procedures, and standards to increase efficiency.
• Evaluate product integrity and provide disposition for damaged Freights Claim product to Transportation and Inventory teams; provide information about condition and ability to salvage.
• Ensure shipments are from properly licensed vendors and licenses are on file. Maintain electronic logs and utilize online, state provided license-tracking tools. Obtain licenses for unlicensed suppliers.

Education

• High School Diploma or equivalent.

Work Experience

• At least 1 year of quality control experience in a regulated industry setting.

Knowledge / Skills / Abilities

• Ability to perform basic math (addition and subtraction).
• Intermediate level skill in Microsoft Excel (for example: using SUM function, setting borders, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling).
• Intermediate level skill in Microsoft Word (for example: inserting headers, page breaks, page numbers and tables and/or adjusting table columns).
• Position also requires:
  • Use of simple measurement tools such as a ruler, caliper, eyeglass comparator, micrometer, etc.
  • Sitting, walking or standing for prolonged periods of time, with frequent bending and kneeling.
  • Close vision, distance vision, depth perception and ability to adjust focus.
  • Working in hot and cold environments, (32F – 95F), and at heights.
  • Ability to regularly lift up to 50 lbs.
  • Ability to operate material handling equipment.
• May be required to travel from state to state for training or distribution center support.

PREFERRED JOB REQUIREMENTS

• At least 1 year of experience as a QC Inspector in medical device and/or drug manufacturing setting.
• Experience adhering to ANSI/ASQC quality control guidelines.
• Experience adhering to FDA/QSR/ISO14551 guidelines.