Sr Hardware Quality Engineer

Position: Sr Hardware Quality Engineer

Location : Louisville, KY

Duration : 9+ 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
Candidate will site on site in Louisville

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• 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.

V. MUELLER/OWENS& MINOR SPECIFIC RESPONSIBILITIES include the following. Other duties may be assigned.
• 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 .

QUALIFICATIONS
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management. May require consultation and direction to complete the essential duties and responsibilities
• 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

EDUCATION and/or EXPERIENCE
• 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.

LANGUAGE SKILLS
Ability to read and comprehend verbal and written instructions. Ability to effectively present information in one-on-one and group situations to supervisor, management and other employees of the organization.

MATHEMATICAL SKILLS
• College level mathematical skills.
• Basic applied statistics.

REASONING ABILITY
Problems will be approached logically and methodically and be able to develop solutions and/or options. Judgment must be made by considering a few important facts. Written rules, precedents, and policies are available for guiding decisions, but are not always easily obtained. Decisions are made frequently but are rarely needed immediately. As work and/or other responsibilities increase, so do the level of complexity and the importance of decision-making.

Physical Demands
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment
• Office and manufacturing environments
• May include visits to other BD V. Mueller facilities or their suppliers.