Leads & Managers Unique III

Title: Leads & Managers Unique III Location: Lake County IL (hybrid but open to remote) Duration: 06+ Months Pay Range: $85/hr - $87.5/hro Serves as the primary quality lead for project activities to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of the project. o Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures. o Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product/device. Analyze and justify the impact on cumulative changes. o Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required. o 5+ years of total combined experience. At least 3 years in Device Design Quality Assurance Top Skills: o Deep understanding of DHF structure and traceability between DHF elements. o Knowledge and a comprehensive understanding of combination products, medical devices and design controls. o Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control. o Well-versed in risk management methodologies and their application. o Work independently and in a global team environment, and with all levels of personnel within the organization. Bachelor of Science; 4-year pharma, health care, or regulated industry 1. Systems Engineering experience 2. Relational database experience. " What type of environment is this person working in? o Combination of both Group and Individual " Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours? o 40 hour work week, start and end time negotiable but would like good overlap with core business hours 8:30 4:30 central. Overtime is possible in extenuating circumstances but is not typically allowed. " Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e., 1 day remote, 4 days on-site)? o If located in lake county, expectation that hybrid Tues Thurs in office hours are held. If remote, visit lake county 1 wk/month. Interview Process " Please define your required Interview Process (Phone or in-person interview) Phone and video interview. Will meet in person if in Lake County. " Who will be involved in the interview process? Please list full name, contact and confirm time zone.