Fda jobs in wilmington, de

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

CMC Regulatory Affairs Consultant

Wilmington, Delaware

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5d ago

CMC Regulatory Affairs ConsultantJob Type: Contract 12 Months Location: Wilmington, DE Hybrid/Onsite Work Arrangement: 3 Days Onsite per Week Non-Negotiable Required QualificationsBachelor''s degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.Strong hands-on experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.Experience supporting large molecules and/or small molecules.Experience wit

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Contract, Third Party

Depends on Experience

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

Senior Test Method Validation (TMV) Subject Matter Expert (SME) / Lead

Delaware City, Delaware

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13d ago

Less of a LEAD and MORE of an SME Hands On Senior Level Subject Matter Expert ONSITE Title: TMV Engineer SME Daily duties of the contractor: TMV Engineer/specialist Key Requirement and experience: Develop and validate test methods for complex electromechanical medical device systems to verify essential clinical and system performance requirements. Demonstrate expertise in converting design and clinical requirements into repeatable, reproducible, and validation-ready test methods, including de

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Contract

$50 - $55

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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Contract

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

Auditor

Remote or Chicago, Illinois

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Yesterday

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

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 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

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

Product Quality Engineer 1

Newark, Delaware

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Today

Job Description Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation to post market feedback and complaints from the field. Works with cross functional team in implementation of improvements or corrections based on the results of complaint investigations. Essential Duties and Responsibilities Own Investigations and associated root cause analysis, in

Full-time

USD 54,900.00 - 86,000.00 per year

Product Quality Engineer 2

Newark, Delaware

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Today

Job Description Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation to post market feedback and complaints from the field. Lead cross functional team in implementation of improvements or corrections based on the results of complaint investigations. Essential Duties and Responsibilities Provide input in prioritization of complaints and investigation

Full-time

USD 78,000.00 - 122,100.00 per year

Manager, Engineering

Newark, Delaware

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Today

Job Description Why Hologic: Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping ;healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence. What to expect: The Manager of Manufacturing Engineering leads a team of engineers and technicians responsible for developing, improving, and supporting manufacturing processes, equipment, and tools. This role ensures tha

Full-time

USD 122,000.00 - 200,000.00 per year

CAPA Facilitator, Engineer

Newark, Delaware

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Today

Job Description Hologic is seeking a Quality Engineer, CAPA Facilitator to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner closely with Quality Management System, QMS, leadership and cross-functional teams to improve CAPA performance, support remediation efforts, build CAPA competency, and help sustain effective quality systems. The ideal candidate brings strong experience in quality assurance within a r

Full-time

USD 97,600.00 - 152,700.00 per year

SAP Batch Release Hub (BRH) SME

Philadelphia, Pennsylvania

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Today

job summary: We are seeking a Senior SAP Batch Release Hub (BRH) Subject Matter Expert to drive solution sustainment, production support, and regulatory compliance for global Life Sciences operations. In this role, you will lead L2 support, incident management, and system integrations between SAP S/4HANA QM and key manufacturing platforms. You will play a pivotal role in ensuring smooth go-live transitions, hypercare execution, and overall operational efficiency in a highly regulated environmen

Contract

USD67 - USD77

Senior Embedded Firmware Engineer / Medical Devices

King of Prussia, Pennsylvania

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Today

We are partnered with a leading medical device company that develops innovative technologies for spinal, orthopedic, trauma, and joint reconstruction procedures. They are looking to hire a Senior Firmware Engineer to join their Spinal team, developing next-generation implantable medical devices that help restore mobility and improve the quality of life for patients recovering from spinal injuries. This is a highly impactful engineering role where you'll own firmware development throughout the en

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Full-time

$150000 - $165000

SAP Batch Release Hub SME

Hybrid in Philadelphia, Pennsylvania

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6d ago

Title: SAP Batch Release Hub SME Location: Philadelphia, PA (Hybrid- 2 days in a week) Duration: 8 Months Job Responsibilities: Lead SAP Batch Release Hub (BRH) solution design and sustainment activities for Life Sciences clients, translating business, quality, manufacturing, and regulatory requirements into scalable and compliant end-to-end solutions. Demonstrate strong expertise in SAP BRH, SAP S/4HANA QM, batch management, inspection lots, usage decisions, quality notifications, batch

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Contract, Third Party

Depends on Experience

Senior Software Design Assurance Engineer

Newark, Delaware

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Today

Job Description The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls, driving rigorous verification and validation processes, and collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices. Kn

Full-time

USD 97,600.00 - 152,700.00 per year

Product Quality Engineer 3

Newark, Delaware

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Today

Job Description Hologic is a global medical technology company focused on women's health and wellbeing. Our Newark, Delaware team manufactures the 3Dimensions Mammography System, recognized as the "Coolest Thing Made in Delaware," which helps detect breast cancer earlier and with greater certainty. Join a high-growth, world-class manufacturing facility producing life-saving medical devices. Job Summary: Product Quality Engineer will make a direct impact on patient safety and product excellen

Full-time

USD 85,300.00 - 133,000.00 per year

Fda jobs in Wilmington, DE, USA