Engineer IIOnsite in Naperville, IL year, W-2 ContractPay: $40 to $45/hr.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and company systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.Key Responsibilities:Investigate moderately complex manufacturing product quality and compliance issues which may include:Investigate PRAs and complaints for manufacturing related issuesManage site NCRs, CAPAs, ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze resultsProvide technical support to external and internal auditsMake recommendations and develop reportsOversee 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 transfersMay 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 processesProvides support to the following:Process validation or support/lead TMVSustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control etc.Education/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 skillsBasic understanding of statistical techniquesPrevious experience working with lab/industrial equipmentSolid understanding and knowledge of principles, theories, and concepts relevant to EngineeringSolid problem-solving, organizational, analytical and critical thinking skillsSolid understanding of processes and equipment used in assigned workKnowledge of and adherence to Quality systemsStrict attention to detailAll qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.