Sr. Quality Engineer

Essential Duties and Responsibilities

• Performs gap assessments pertaining to purchased materials specification.
• Creates/revises current product specifications via Change Control / Project Plans.
• 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.

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 GD&T concepts, metrology, typical supplier management processes, Engineering Drawing conventions/configuration types, etc.
• 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