Sr Hardware Quality Engineer

• Represents the Corporation, Division and Quality Department in a professional manner as an on-site V. Mueller Quality Representative/Liaison with Owens & Minor Quality Engineering, Operations, and Value-Added Services (VAS) groups
• Creates/reviews Protocols, Process and Product Validations as required
• Creates and reviews Test Methods and addresses Test Method Validation
• Creates and reviews documents required for Design History File
• Creates and reviews Risk Assessments such as FMEA, FMECA or FTA
• Ensures compliance to V. Mueller Quality Department and BDI- Surgery policies and procedures
• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner
• Interfaces with V. Mueller manufacturing facilities or other Division Facilities
• Supports root cause investigations and other steps of the CAPA process
• Travels as required by the above duties and responsibilities
• 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 in Engineering, Engineering Technology, Science a minimum
• Minimum 1 year of experience with FDA regulated industry, preferably on product development programs
• Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management
• Understands basic applied statistics
• Ability to participate on teams and maintain positive work environment
• Good communication skills (verbal, written, and presentation)
• Understands Basic Fundamentals of Engineering Principles
• Ability to effectively manage time
• Ability to handle multiple task assignments
• Ability to translate quality requirements into product specifications
• Ability to interpret Regulations, Corporate, Division and Department Procedures

American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred