Job Title: Sr. Quality Engineer

Location: Vernon Hills, IL

Duration: 5+ Months

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

This position performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Supplier Quality Assurance/Document Control. This includes working to primarily support V. Mueller Platform Quality in efforts to address potential gaps in current product specifications for purchased materials, and 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.
• 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
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 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
 

EDUCATION and/or EXPERIENCE
• BS in Engineering, Engineering Technology, Science a minimum
• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
• Minimum 3 years of experience with FDA regulated industry, preferably managing supplier relationships/specification management.