New 
Quality Lead
 Spectraforce Technologies | |
 United States, Illinois, Waukegan | |
 May 06, 2026 | |
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Title: Quality Lead Duration: 8 Months (End of 2026) Location: North Chicago, IL 60064 (hybrid but open to remote) o 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. * Are you open to look at candidates who are willing to relocate? Yes * Years of experience/education and/or certifications required: 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 * What are the top 3-5 skills requirements should this person have? 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. * What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Examples: 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. * Is the worker onshore or offshore? Onshore * Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling: No * Reason for opening this role: Support of DHF reconfiguration project. 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. Sean Cradick, contact information in email signature, Lake County, IL. | |