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Sr Hardware Quality Engineer

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MillenniumSoft Inc

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Location:
United States , Louisville, KY ▼

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

48.00 - 52.00 USD / Hour
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Job Description:

This position performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance/Document Control. This includes working to primarily support the V. Mueller Platform Quality relationship with Owens & Minor Healthcare Logistics (OMHCL) as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments.

Job Responsibility:

  • 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

Requirements:

  • BS in Engineering, Engineering Technology, Science a minimum
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
  • 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 with those teams
  • 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
  • Ability to read and comprehend verbal and written instructions
  • Ability to effectively present information
  • College level mathematical skills
  • Basic applied statistics
  • Problems will be approached logically and methodically and be able to develop solutions and/or options
  • Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear
  • May occasionally lift objects of 10 to 25 lbs

Nice to have:

  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
  • Experience with FDA regulated industry, preferably on product development programs

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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