Quality Engineer II - Contract

Position: Quality Engineer II,Req#: 18764-1
Location: Naperville, IL (100% Onsite)
Duration: 12+ Months Contract

This role will work in the Quality Engineering team to support manufacturing and sustaining engineering activities. Must have experience in Quality, ideally with ownership of NCRs, CAPAs and oversight of changes to ensure conformity to applicable requirements (ISO 13485, FDA 21 CFR 820 and the QMSR).

Job Description:

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client’s systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Education and Experience: 

• Bachelor's degree in engineering required.
• 2-4 years' experience required.

Additional Skills:

• Good computer skills in usage of MS Office Suite
• Ability to read and interpret drawings
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control

Job Responsibilities: 

• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes before final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Assign support tasks; give instructions to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership