Product Quality Senior Manager AbbVie IncProduct Quality Senior ManagerNorth Chicago, ILEstablishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns. Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
Clinical Account Educator iRhythm TechnologiesClinical Account EducatorDeerfield, IL$91,000–$118,000 / yearThe Clinical Account Educator serves as the primary clinical contact for healthcare providers, supporting appropriate use of ambulatory cardiac monitoring services while managing conversations around off-label and/or investigational uses. 3-5 years in a clinical educator, or similar role, particularly in a regulated environment such as diagnostics, biomedical devices and/or experience supporting cardiac monitoring IDTFs (Clinical and/or Commercial support).
Principal System Engineer Full SpectrumPrincipal System EngineerLincolnshire, ILThe Opportunity: Strategic Leadership & Client Impact: In this high-visibility role, you serve as the primary technical interface for our clients, driving Software Systems Engineering for mission-critical medical device projects: Lead & Delegate: Manage project execution by aligning client needs with team tasks and deliverables. Safety Risk Analysis: Lead planning for complex software-driven medical devices, perform top-down hazard and harm assessment working with Full Spectrum clients’ clinical tam or medical director, performing bottom-up failure analysis (FMEA) and identifying potential risk to safety.
Senior Design Assurance Quality Engineer I-II Hollister IncSenior Design Assurance Quality Engineer I-IILibertyville, IL$90,000–$125,000 / yearUtilize parametric and nonparametric statistical analysis methods (including ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, control charts, regression analysis, survival analysis, MSA, acceptance sampling ANSI/ASQ Z1.4 & Z1.9) to ensure products/processes are appropriately characterized and qualified prior to market release. Design Assurance Quality Engineer functions as a project core team member, representing Global Quality and Regulatory Affairs (GQRA) on new product development and change management projects committing to support product/project objectives, driving and participating in business decisions, and assuming accountability for product/project success.
Clinical Account Educator iRhythmClinical Account EducatorDeerfield, IllinoisThe Clinical Account Educator serves as the primary clinical contact for healthcare providers, supporting appropriate use of ambulatory cardiac monitoring services while managing conversations around off-label and/or investigational uses. 3–5 years in a clinical educator, or similar role, particularly in a regulated environment such as diagnostics, biomedical devices and/or experience supporting cardiac monitoring IDTFs (Clinical and/or Commercial support).
Project Manager - Quality Remediation Programs Flex LtdProject Manager - Quality Remediation ProgramsBuffalo Grove, IL$89,200–$122,700 / yearThe Project Manager - Quality Remediation Programs is responsible for leading complex, cross-functional remediation initiatives to address quality system gaps, regulatory findings, and operational risks. The role requires strong program governance, stakeholder alignment, and the ability to operate under high-pressure, high-visibility conditions (e.g., audit observations, warning letters, or compliance commitments).
NewQuality Assurance Manager Actalent IncQuality Assurance ManagerMorton Grove, IL$120,000–$140,000 / yearWe are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Registry Systems and Reporting Specialist - Schaumburg, IL (Flexible Hybrid Schedule) American Society of AnesthesiologistsRegistry Systems and Reporting Specialist - Schaumburg, IL (Flexible Hybrid Schedule)Schaumburg, IL$75,000–$95,000 / yearPart timeSupports user acceptance testing (UAT), regression testing, production validation, and release verification activities related to registry enhancements and participant data submissions; documents testing results, root cause analyses, corrective actions, support resolutions, and recommended process improvements. · Leverages generative AI, large language models (LLMs), natural language processing (NLP), and other emerging technologies to enhance registry operations, streamline data validation activities, accelerate issue investigation, and improve participant support processes while adhering to AQI and ASA governance, privacy, and security requirements.
Quality Assurance Specialist Microbac Laboratories IncQuality Assurance SpecialistNorthbrook, ILLeads, plans, organizes, and supports the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory including but not limited to document control, CAPA, internal audits, control charts & trend analysis, in-depth data monitoring, approved suppliers and validation of methods, systems & instrumentation. Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients nationwide, offering laboratory solutions to life science, food and nutrition, and environmental industries and serves our clients with the utmost expertise and respect for their market requirements, constraints, and challenges.
Quality Systems Manager BISCO, Inc.Quality Systems ManagerSchaumburg, ILFull timeThe ideal candidate is a practical quality leader who can manage and coach direct and indirect reports, maintain quality system discipline, analyze data and trends, and drive timely follow-through on quality issues. BISCO is seeking a Quality Systems Manager to manage and maintain BISCO’s Quality Management System and oversee key QA/QC activities in support of ISO 13485 and applicable medical device regulatory requirements.
Associate Director International Marketing Strategic Lead - Immunology AbbVie IncAssociate Director International Marketing Strategic Lead - ImmunologyILThe role requires close collaboration with a broad cross-functional network, including market access, medical affairs, regulatory, legal, health economics, public affairs, medical and regulatory review, patient relations, business insights, OEC, global learning, and US counterparts. This position is responsible for ensuring the strategy remains relevant, competitive, and consistent across geographies by translating insights into actionable brand direction and supporting execution through the International Brand Team, regional teams, and affiliates.
Sunshine Act Compliance Consultant MRA Recruiting ServicesSunshine Act Compliance ConsultantMcHenry, ILThe consultant will evaluate our current processes, identify reportable transactions, work cross-functionally to gather and validate required data, prepare the annual reporting files, and develop sustainable procedures that enable our internal team to successfully manage future reporting cycles. As one of the largest employer associations in the nation, MRA helps its member organizations thrive by offering the most comprehensive assortment of HR services, information, education, and resources to help build successful workplaces and a powerful workforce.
Director of RA CMC Knowledge Management & Strategy AbbVie IncDirector of RA CMC Knowledge Management & StrategyNorth Chicago, ILThe Knowledge Management and Strategic Initiatives role will develop & advocate strategic positions for CMC regulatory/CMC issues with cross functional internal stakeholders and on behalf of AbbVie in key areas that will meaningfully impact acceleration of AbbVie's portfolio. Collaborate with RA CMC regional SMEs to monitor and address emerging regulatory CMC trends across global markets, ensuring proactive regulatory compliance, knowledge sharing and maintenance of AbbVie's Reg Requirements Portal.
Medical Lead Oncology MA-US NSCLC Astellas Pharma IncMedical Lead Oncology MA-US NSCLCNorthbrook, ILcollaboration with key stakeholders across the company to support business objectives for the US Region, leading the Regional Medical Team (RMT), as applicable, and ensuring alignment with and support of Medical Affairs (MA) colleagues within the region. Drive scientific and medical development and approval of sound study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies, ensuring clinical and scientific accuracy.
Senior Manager Clinical Quality Assurance AbbVie IncSenior Manager Clinical Quality AssuranceNorth Chicago, ILInteract with Development Operations organization and supporting functions to ensure quality compliance across all aspects of clinical development; Identify and mitigate potential clinical quality risks and escalate to management; Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities; Provide project/program leadership in quality as a team member across clinical development functions. As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a "fit for purpose" audit program with the goal of submission-ready quality data, first pass approvals by health authorities for market authorizations, and bringing our compounds to our patients.
Senior Design Verification Engineer I AbbVie IncSenior Design Verification Engineer INorth Chicago, ILWe are looking for an experienced Senior Scientist I, Engineering - Design Verification Engineer to join our Combination Product Development & Drug Delivery Team to contribute to the development of exciting new drug / device combination products. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position.
Quality Assurance Manager MRINetwork JobsQuality Assurance ManagerItasca, IllinoisThe Quality Manager is responsible for leading the Quality Assurance function and overseeing the Quality Management System (QMS) to ensure that all medical devices comply with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable global regulatory requirements. Participate in post-market surveillance activities, including complaint handling, MDRs/adverse event reporting, trend analysis, and implementation of corrective actions.
Senior Analyst, Certification Engineer Whirlpool CorpSenior Analyst, Certification EngineerMt Pleasant, WIAs the only major U.S.-based manufacturer of kitchen and laundry appliances, the company is driving meaningful innovation to meet the evolving needs of consumers through its iconic brand portfolio, including Whirlpool, KitchenAid, JennAir, Maytag, Amana, Brastemp, Consul, and InSinkErator. The Engineering team discovers, develops and evaluates new product ideas, enhancements, or strategic product extensions, and translates research discoveries into usable and marketable products.
NewUPLIZNA gMG Senior Associate, HCP Marketing Amgen IncUPLIZNA gMG Senior Associate, HCP MarketingDeerfield, ILIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Working closely with HCP marketing leadership, agency partners, and cross-functional stakeholders, this individual will help bring commercial strategy to life by coordinating marketing projects, supporting development of promotional materials, and ensuring flawless execution of key commercial initiatives.
Associate Director International Marketing & Commercial Operations Oncology AbbVie IncAssociate Director International Marketing & Commercial Operations OncologyILThe position involves heavy collaboration within a matrixed team, including but not limited to: market access, medical affairs, pipeline, finance, regulatory, legal, supply operations, health economics, clinical development, R&D, public affairs, medical and regulatory review, patient relations, business insights, OEC, and sales training. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.