Sr. Quality Engineer

Position: Sr. Quality Engineer

Location : Louisville, KY

Duration : 8+ Months contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1b’s

Description:

LOCATION:
This position will be based out of Louisville, Kentucky location. Candidate needs to be onsite and work with our distributor. He/She will represent BD at our 3PL.

Distributor Address: 6201 Global Distribution Way #101, Louisville KY 40228

Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument distribution center.
• Provides on-site guidance to OMHCL Quality Engineering, test technicians/quality inspectors as required to ensure training is current and qualifications of Owens Engineering and VAS employees is adequate to perform necessary responsibilities.
• Interfaces daily with Owens & Minor teams to ensure inspection of V. Mueller product is performed and results accurately documented and reported in a timely manner in accordance with V. Mueller and product requirements.
• Provides oversight for Returned Goods inspections, Scrap processing, and Kitting Operations.

• Drives quality related issues to prompt closure by working with V. Mueller Platform Quality Engineering/Marketing/R&D functions and Owens Operations and Quality Teams.
• Co-Leads Material Review Board in partnership with Owens & Minor Quality Engineering. Creates, reviews, and approves all V. Mueller Nonconformance Reports (NCRs). Responsible for managing performance metrics, various trend analyses, etc. together with BD Lead Coordinator.
• Generates new NCR’s, manages dispositions, rework, sort, and scrap activities thorough final closure. Coordinates with Owens& Minor Quality Engineering to ensure all inspection related documentation is reviewed, approved, and stored per current requirements.
• Creates, reviews, and approves both BD and OMHCL Quality System Documents/Procedures associated with V. Mueller products. Ensures Specifications are current and readily available. Ensures alignment of BD and Owens & Minor V. Mueller procedures. Has responsibility to initiate Engineering Change Management projects to update specifications where required.
• Performs Owens & Minor Supplier Quality System Audits .

BS or BA in related field required with 2 years of experience, or MS with no experience required (project management experience preferred).

Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field. Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.

Capable of using Microsoft programs and ability to learn other systems. Working knowledge of statistical methods as well as statistical application software. Effective verbal and written communication skills. The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).