Sr. Quality Engineer

About the role

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.

Responsibilities

• Reviews and assesses 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).
• Manages 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.
• 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.
• Initiates Engineering Change Management projects to update specifications where required.
• Performs Owens & Minor Supplier Quality System Audits.

Requirements

• BS or BA in related field required with 2 years of experience, or MS with no experience required (project management experience preferred).
• 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.
• 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.
• Self-motivated/directed, organized, detail oriented and have ability to multi-task projects.

Qualifications

• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).