Quality Engineer II

Position: Quality Engineer II, Req#: 18366-1
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 Edwards' 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 documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment
• 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 which may include:

• Investigate PRAs and complaints for manufacturing related issues
• Manage site NCRs, CAPAs, ECRs and audit observations for all production processes before final product release based on engineering principles; analyze results,
• Provide technical support to external and internal audits,
• Make recommendations and develop reports.

• Oversee product release, assess and disposition product on hold (MRB), and manage material quality control.
• Review and approve equipment validations and asset management actions.
• Collaborate with engineering teams to ensure successful transfers
• May develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Provides support to the following:

• Process validation or support/lead TMV
• Sustaining Quality Engineering responsibilities such as reviewing Quality Metrics, Material Review Boards, Quality Control, etc.

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