Quality Engineer

Quality EngineerThe Quality Engineer will develop, implement, and maintain quality assurance plans, analyze data to drive continuous improvement, and provide technical mentorship to the quality assurance team. The role involves representing the quality function in technical support, collaborating with other internal support groups on issues affecting manufacturing on global customer accounts, and serving as a liaison between the company, suppliers, and customers on global quality-related issues.ResponsibilitiesDevelop, maintain, and improve quality management system procedures to support governing standards.Lead root cause analysis sessions with cross-functional working groups and assist with implementing corrective and preventive actions (CAPA) for non-conformances.Analyze production and development data to identify trends, defects, and opportunities for improvement.Support and review the execution of process validation protocols and test method validation, including development of measurement methods or functional test methods.Provide support for all quoting activities by participating in initial process design, development, and implementation phases.Evaluate and provide input to inspection processes via inspection aids and instruction guidelines.Support global training programs specific to the customer by developing and implementing specialized training sessions for all applicable functions.Develop appropriate systems for document storage, access, and review pertaining to global customer accounts.Review all supplies, internal, and customer discrepancies, and coordinate and track the effectiveness of corrective and proactive action efforts.Conduct periodic review and maintenance of all documentation files.Participate in vendor survey activities and drive proactive participation with suppliers, aiding in their process improvement efforts when possible.Interface with all departments as applied to the company's policies and procedures.Provide insight and assistance in implementing and maintaining process improvement and optimization concentrating on proactive methodologies.Assist in driving the standardization of manufacturing processes for global customer accounts.Interface and provide technical support on quality issues with the customer as needed.Essential SkillsProficiency in quality engineering, ISO standards, and medical device manufacturing.Experience with supplier quality, root cause analysis, CAPA, and quality management systems (QMS).Proficiency in statistical analysis, statistical process control, root cause analysis tools, and risk management.Strong analytical, leadership, and communication skills.Experience with injection molded plastic parts and audit processes.Additional Skills & QualificationsMinimum bachelor's degree in engineering, quality, or related technical field.5+ years of related experience in a quality engineering role, preferably in medical device manufacturing.ASQ certification preferred.Proficiency with Minitab and standard Microsoft Office Suite, including Excel.Experience with ERP systems such as SAP, Oracle, or IQMS.Work EnvironmentThe position is based in a manufacturing environment, focusing on injection molding of medical products and adhering to ISO 13485 standards.Job Type & LocationThis is a Contract position based out of Gages Lake, IL.Pay and BenefitsThe pay range for this position is $42.00 - $46.00/hr.Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Gages Lake, IL.Application DeadlineThis position is anticipated to close on Aug 28, 2026.