FDA Jobs in Michigan

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CQV Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in

Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye

Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLC

Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol

Senior Staff, Software Quality Assurance Engineer

Stryker

Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must resi

Clinical Data manager

Intone Networks Inc.

Remote

Third Party, Contract

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T

Project Manager

Beacon Systems, Inc

Lansing, Michigan, USA

Third Party, Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Project Manager Location: Onsite - Lansing, MI Duration: Long term Key Responsibilit

JD EDWARD DEVELOPER

Virisha LLC

Remote

Contract

JD Edwards E1 Developer 100% REMOTE but open to working core CST hours 6 month contract to hire Job Description: PREFERRED QUALIFICATIONS: Experience with JDE 9.2+ and Tools Release 9.2.x.Familiarity with BI Publisher, JDE Security, and Workflow.Experience integrating JDE with third-party systems using REST/SOAP APIs.Background in Agile/Scrum or DevOps environments.DUTIES AND RESPONSIBILITIES: Lead the design, development, and implementation of complex customizations and enhancements in JD Edw

Job Title: Product Manager Healthcare Remote

Think Big Solutions, Inc

Remote

Contract

Job Title: Product Manager Healthcare Location: [City, State or Remote] Job Type: [Full-Time / Part-Time / Contract] Job Summary: We are seeking an experienced and strategic Product Manager with a background in healthcare to lead the development and execution of products that improve patient outcomes, provider workflows, or payer efficiency. The ideal candidate will have a strong understanding of healthcare systems, regulations (e.g., HIPAA, HL7, FHIR), and the complexities of healthcare deliver

Sales head

Showman Staffing

Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required(100% travel) Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring cutting-edge technology solutions to life. You will repr

DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLC

Remote or King of Prussia, Pennsylvania, USA

Third Party, Contract

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

(2) Process Engineer - SAP Implementation

Primary Talent Partners

Dexter, Michigan, USA

Contract

Primary Talent Partners has an exciting opportunity for TWO SAP Engineers in Dexter, MI to help assist our Medical Device client with a major SAP implementation. Please see details below and apply if qualified and interested!Logistics:Client: Confidential Medical Device ManufacturerJob Title: SAP Implementation Engineer - Documentation & BOMsLength: 6-month contract (possible extension)Location: Dexter, MI - 100% onsiteSchedule/Hours: Full-time, standard business hoursPay Range: $55-$70/hr on ou

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new

Engineer III, Validation

Thermo Fisher Scientific

Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn

Senior Appian Developer

General Dynamics

Remote

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on

Sr. R&D Engineer

Johnson & Johnson

Remote or New Brighton, Minnesota, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Data Architect/ Engineer(Remote)

Kellton

Remote

Contract

This is a long term remote position with one of our major pharmaceutical clients. This role is 100 percent remote. SUMMARY OF POSITION: The Database Architect will be responsible for the management of Oracle and SQLServer database environments hosted at a 3rd party datacenter. The 3rd party will provide day-to-day support and monitoring services. This position will work closely with and manage the hosting partner in order to keep the environment performing to established service level agreements