Quality Engineer II

Position: Quality Engineer II Req#: 18764-1
Location: Naperville IL(100% Onsite)
Duration: 12Months 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 clients systems/procedures to optimize product development internal and external device manufacturing and device distribution.

Education and Experience:

• Bachelors 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

Why TalentBurst
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Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.