Sr Hardware Quality Engineer

Essential Duties and Responsibilities

• 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

• 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

• 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.

Work Environment

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