Sr. Quality Engineer

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 support tasks in developing knowledge and experience in Supplier Quality Assurance/Document Control. It primarily supports V. Mueller Platform Quality in addressing gaps in product specifications for purchased materials and supports the Quality System, Design Control System, Document Control, Manufacturing, and R&D/Product Development departments.

Sr. Quality Engineer

Vernon Hills, IL

5+ Months

• Performs gap assessments pertaining to purchased materials specification.
• Creates and revises current product specifications via Change Control and Project Plans.
• Creates and reviews protocols, process and product validations.
• 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 state‑of‑the‑art industry standards are communicated into the division efficiently.
• 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.

• Ability to perform detailed engineering work under the direction of a Senior Engineer or Quality Management.
• Understands basic applied GD&T concepts, metrology, typical supplier management processes, and engineering drawing conventions.
• Ability to participate in teams and maintain a positive work environment.
• Good communication skills (verbal, written, and presentation).
• Understands basic fundamentals of engineering principles.
• Ability to effectively manage time and handle multiple task assignments.
• Ability to translate quality requirements into product specifications.
• Ability to interpret regulations, corporate, division, and department procedures.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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