FDA jobs in Crystal Lake, IL

Remote

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6d ago

POSITION TITLE:Information Technology Specialist - FDA LOCATION:Remote CLEARANCE:Must be able to obtain aHigh-RiskPublic Trust COMPANY OVERVIEW At APV,weremore than a technology company werea mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Ourexpertisespans AI/ML, data architecture, low-code/no-code development, AgileDevSecOps, and cloud services, delivering scalable and meaningful solutions. In our Emerging Technology Lab, innovation drive

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Contract

Depends on Experience

Quality manger

Hybrid in Crystal Lake, Illinois

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12d ago

Role Summary We are seeking an experienced Quality Manager for a manufacturing facility based in Crystal Lake. This role reports directly to the Plant Manager and is responsible for leading the sites Quality Management System, ensuring compliance with ISO standards, and driving continuous improvement across all quality-related functions. The ideal candidate is a hands-on quality leader who can balance strategic oversight with operational execution while building a strong quality culture across t

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Full-time

90,000 - 100,000

Software Quality Assurance Engineer (Medical Device) - Only On W2

Lake Forest, Illinois

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4d ago

Position SummaryThe Software Quality Assurance Engineer will be responsible for ensuring regulatory compliance and quality assurance for healthcare software products. This role focuses on supporting quality system compliance activities, software validation efforts, risk management processes, and regulatory requirements within a highly regulated healthcare environment. The ideal candidate will work independently, partner with cross-functional teams across multiple geographic locations, and help

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Contract

35 - 40

Auditor

Remote or Chicago, Illinois

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Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Senior Android Developer

Remote

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6d ago

HiAssociate, Greetingsfor theday, We have a position as aSenior Android Engineerrole forRemote.Please find the job description below for this position. Role:Senior Android Engineer Location: Remote Duration: 24 Months Note: Healthcare or Medical Device experience is mandatory. Key Responsibilities: Triage and debug field issues reported by users of our Android applications. Analyze crash reports, logs, and other diagnostic data to identify the root cause of issues. Develop understanding of ex

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Contract

Depends on Experience

SAP QM Architect

Remote

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26d ago

SAP QM ArchitectThe SAP Quality Management (QM) Architect leads the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment. The role requires deep expertise in QM processes, strong cross-module integration skills, and hands-on experience across implementations, rollouts, and upgrades. The architect ensures quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems. Respon

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Depends on Experience

Regulatory Specialist

Remote

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2d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

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Contract

Depends on Experience

Clinical Research Scientist III - (Director/Assoc. Director level)

Remote or Hybrid in Parsippany-Troy Hills, New Jersey

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10d ago

Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols. Participates in protocol review discussions concerning scientific and procedural aspects of study design. Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision. With supervision, contributes to the design and development of CRFs, Data Management Manuals and Da

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Third Party, Contract

$100 - $110

QA Test Engineer

Remote

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24d ago

Blu Omega is seeking a QA Test Engineer to support a federal program focused on data validation and workflow testing within the FDAs Regulated Product Submission (RPS) program. This role operates in a remote environment and is responsible for executing functional, integration, and data verification tests. The position requires experience supporting testing efforts in a mission-driven environment, with a focus on data accuracy, integrity, and consistency. Program Overview Program: FDA Regulated P

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Full-time

125,000 - 135,000

Clinical Information Specialist with Womens Health Clinical Practice (W2 ONLY)

Remote

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2d ago

Clinical Information Specialist / W2 ONLY / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experienced Clinical Information Specialist with at least 5 years of experience, in Women s Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Pra

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Contract

Depends on Experience

SAP Security Consultant - Remote

Remote

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4d ago

Title: SAP Security Consultant - Remote Mandatory skills: SAP GRC, AC/PC, SAP BTP Technologies, enterprise-wide system solutions, SAP Security Role Design, user administration, SAP security requirements, SOX, FDA validation, SAP authorization management, SHS compliance requirements, SAP Audit Management, SAP ECC, S/4 HANA, SAP HANA, SAP BI NetWeaver, Fiori, SAP RISE, SAP GTS, SAP NFP, SAP MES, SAP BI systems, supporting tools, Security Weaver, SHARP, SAP role management, SAP Identity Management,

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Contract

52 - 57

Senior Engineer, UI/UX

Round Lake, Illinois

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Today

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboratio

Full-time

USD 96,000.00 - 132,000.00 per year

Validation Engineer

Round Lake, Illinois

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Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Engineer III

North Chicago, Illinois

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Today

Roles& Responsibilities: The Combination and Medical Device Products Consumable Device US team is expanding its support for on-market devices. This role will be responsible for on-market change execution, product lifecycle management, and manufacturing support specific to the product design. Proficiency with medical device/pharmaceutical DHF traceability is required. Proficiency with test execution, deviation reporting and management, data review, and report writing is required. Experience with

Full-time

Principal Systems Verification Engineer

Round Lake, Illinois

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Today

Full-time

USD 112,000.00 - 154,000.00 per year

Principal System Engineer

Lincolnshire, Illinois

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Today

Full Spectrum partners with leading companies in MedTech to develop cutting-edge software for medical devices. With projects focused on embedded systems, mobile apps, robotics, engineers at Full Spectrum love the challenge of working with clients on products that have a meaningful impact. Working across different client projects with a wide range of technologies, a career at Full Spectrum offers both technical and professional growth opportunities. Principal System Engineer: At Full Spectrum,

Full-time

USD 150,000.00 - 205,000.00 per year

Senior Human Factors Engineer

Hybrid in Northfield, Illinois

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Today

Job Summary This position is responsible for leading Human Factors and Usability Engineering activities across the product lifecycle to ensure medical devices (Class I and II) are safe and effective for use. This engineer will collaborate with cross-functional project teams to improve product designs (new and existing), specifically the device user interfaces, including the device, packaging, labeling, and instructions for use, while minimizing the potential for use errors. This position will a

Full-time

USD 101,000.00 - 152,000.00 per year

Principal Engineer, R&D

Deerfield, Illinois

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Today

Full-time

USD 112,000.00 - 154,000.00 per year

Project Manager - Pinnacle 21, GXP | 100% Remote | Contract

Remote

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4d ago

Our direct client a large global R&D driven pharmaceuticals company is seeking to hire a Project Manager for their Pinnacle 21 upgrade project.This is 6 months plus contract. Job Title: Project Manager - Pinnacle 21 upgrade project Duration: 6 months (may extend) Location: 100% Remote (work per eastern time)Pinnacle 21 solution is critical for SQS.For this role client is looking for System upgrade experience as a Project Manager and from IT perspective.The tool provides the quality of submissio

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Contract

Depends on Experience

Clinical Information Specialist

Remote

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2d ago

Clinical Information Specialist / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experiencedClinical Information Specialist with at least 5 years of experience, in Womens Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Practice Registe

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Contract

70 - 80

FDA jobs in Crystal Lake, IL, USA