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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl

Chemist

ITS Technologies, Inc.

Bowling Green, Ohio, USA

Full-time

Integrated Talent Strategies (ITS) is seeking a Chemist to work in the Perryburg, OH area. This is a direct hire position that offers a variety of great benefits, including health insurance, 401(k), and paid time off.Description Conducts research, formulation and experimentation for new product development and process improvement. Experience formulating coatings which may include floor, paint, or automotive at the bench. Product development experience working with marketing from concept through

LIMS and QC Applications Consultant

Expedite Technology Solutions

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to

Project Engineer

Jobot

Massillon, Ohio, USA

Full-time

Project Engineering - Global Company - Top Tier Compensation, Benefits and PTO This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $120,000 - $160,000 per year A bit about us: Our client is a global leader in the Food & Beverage industry. They've been in business for over a century and offer top tier compensation, benefits, PTO and upward mobility. Due to the necessity of their industry they are always

Project Engineer

Jobot

Ashland, Ohio, USA

Full-time

Project Engineering - Global Company - Top Tier Compensation, Benefits and PTO This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $120,000 - $160,000 per year A bit about us: Our client is a global leader in the Food & Beverage industry. They've been in business for over a century and offer top tier compensation, benefits, PTO and upward mobility. Due to the necessity of their industry they are always

Project Engineer

Jobot

Wooster, Ohio, USA

Full-time

Project Engineering - Global Company - Top Tier Compensation, Benefits and PTO This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $120,000 - $160,000 per year A bit about us: Our client is a global leader in the Food & Beverage industry. They've been in business for over a century and offer top tier compensation, benefits, PTO and upward mobility. Due to the necessity of their industry they are always

Business Quality Assurance (BQA)

Activesoft, Inc.

Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)

PTC Arena Consultant

Teknikoz

Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an

Project Manager / Director

DTEL Engineering & Consultants Inc

Cleveland, Ohio, USA

Contract

Must-Haves: 12+ years in manufacturing; 5+ years in program/portfolio managementExperience managing budgets over $5MDeep expertise in Lean, Six Sigma, Industry 4.0Proficiency in MS Project, ERP/MES tools (SAP S/4HANA preferred)Excellent executive reporting & cross-functional leadership Key Responsibilities: Lead large-scale programs focused on transformation, efficiency, and tech adoptionBuild strategic roadmaps tied to digital manufacturing goalsAlign with teams across Engineering, Supply Chai

Delta V Automation Engineer

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti

Delta V Automation Engineer

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active

Microbiology Team Lead

ITS Technologies, Inc.

Bowling Green, Ohio, USA

Full-time

Integrated Talent Strategies (ITS) is seeking a Microbiology Team Lead to work in the Perrysburg, OH area. This is a direct hire position that offers a variety of great benefits, including health insurance, 401(k), and paid time off.DescriptionResponsible for USP microbiological quality control testing on various products, including FDA-regulated OTC drugs, cosmetics, and EPA-registered disinfectants. Establishes microbial monitoring limits and oversees environmental monitoring to ensure facili

Drug Safety Scientist

Sunrise Systems, Inc.

Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature

Remote Senior QA Test Manger/QA Leader with Strong Healthcare Domain

Infinite Computer Solutions (ICS)

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Descriptions : We are looking for an experienced Senior QA Healthcare Manager/QA Leader 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: Lead and manage the QA t

Senior Expert Physicist

Spar Information Systems

US

Third Party, Contract

Looking for a Senior-Level Expert-preferably a scientist or physicist-with hands-on experience designing, developing, and troubleshooting magnetic tracking systems, especially in medical device or similar precision environments. Key Requirements: Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical tracking systems. Should be deeply familiar with electromagnetic field be

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

Oracle Field Service Cloud Consultant

Prutech Solutions

Remote

Contract

Job Title: Oracle Field Service Cloud Consultant Duration: Full Time / Contract Location : Remote Required Skills/Experience: Bachelors degree in computer science, Information Technology, Engineering, or a related field.5+ years of experience in implementing and supporting Oracle's Field Service solutions.Strong understanding of and field service processes and best practices.Proven expertise in Oracle's E-Business Suite, Cloud, or other relevant Oracle products.Excellent analytical and problem-

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w

Principal Product Security Engineer (REMOTE)

Stryker

Remote or Portage, Michigan, USA

Full-time

Work Flexibility: Remote Product Security is driven to make healthcare better by ensuring that Stryker designs, develops, and maintains industry leading cyber secure products for our customers. We are seeking a highly skilled Secure Product Lifecycle Expert to ensure the security of our medical devices across their entire lifecycle. This role is critical in embedding robust security practices into our software development lifecycle (SDL), overseeing post-market security management, and integrat