Senior Quality Engineer- Design Quality Lifecycle Management Employer AbbVie Location North Chicago, IL Salary 84500 - 162000 USD Start date Jul 22, 2026 View more categories View less categories Discipline Engineering , Quality , Quality Control Required Education Bachelors Degree Position Type Full time Hotbed BioMidwest , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description Sr. QE for Design Quality Lifecycle Management Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc.

Responsibilities :

Perform QA activities related to

Combination Product and Medical Device Design Transfer and Change Management:

Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Maintain DHF documentation Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management activities such as review 3rd party design control activities Support the creation of regulatory submission documentation Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie. Support equipment qualifications (IQ/OQ/PQ) and process validations Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor them to ensure timely closure Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure. Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions. Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents Apply knowledge of global regulations, guidance's, and Corporate and Function standards. Lead/assist in the preparation of and support regulatory agency and internal audits. Conduct, lead, or participate in investigations and review boards for CAPAs, NCRs, Observations, etc. Participate in departmental Change Control activities, utilizing Design Control knowledge to perform design change impact assessments. Review and approve changes relevant to the department Support interactions with regulatory authorities (e.g., Notified Body audits) Write and revise procedures, forms, and other documents, as needed Work with the cross-functional team to drive change and continuous improvement Qualifications Bachelors degree in engineering, science or other technical areas 6+ years of relevant experience in the medical device industry; 4+ years of Quality Assurance experience required. Strong understanding of regulations and standards affecting combination products and medical devices. Working knowledge of 21 CFR 820, EU

MDR 2017/745, ISO

13485, and

ISO 14971

Working knowledge of Design Control per 21 CFR 820.30 Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management. Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required. Capable of clearly presenting and justifying quality requirements to management Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE). Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this roleat thetimeofthis posting based on the job grade for this position.

Individualcompensation paid within this range will depend on manyfactors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible toparticipate in our short-term incentiveprograms.

Note:

No amount of payis considered to bewages or compensation until such amount isearned, vested, anddeterminable.

Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat areallocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Companys sole and absolutediscretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Company AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Company info Website http:

//www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs API Manufacturing Associate I Clayton, NC Connected Factory Engineer North Chicago, IL Project Engineer Billerica, Massachusetts, United States