21 cfr part 820 jobs

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

COMPONENT ENGINEER 3

Sunnyvale, California

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2d ago

Description: Position Overview The Supplier Engineer is responsible for ensuring suppliers reliably support plant production by meeting Intuitive requirements for quality, delivery, capacity, cost, and service. This role is highly execution-focused and serves as the primary technical interface between the plant and suppliers to resolve line-impacting issues, improve supplier manufacturing processes, and maintain stable production operations across multiple product families. The Supplier

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Contract, Third Party

$60 - $75

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

Validation Engineer

San Jose, California

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Today

Summary: In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards. Roles & Responsibilities: Develop and execute validation plans and reports. Analyze data and troubleshoot process deviations. Ensure compliance with FDA regulations and ISO standards. Collaborate with Engineering an

Full-time

Process Validation Engineer

Irvine, California

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3d ago

Position: Process Validation EngineerLocation: Irvine, CA Key ResponsibilitiesDevelop and execute IQ/OQ/PQ protocols for critical manufacturing processes.Conduct process characterization using DOE, SPC, and statistical modeling.Perform process capability studies (Cp/Cpk) and implement corrective actions for lowcapability processes.Define and maintain the Process Validation Master Plan (PVMP).Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.Support pilottoproducti

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Contract

$35 - $40

Process Validation Engineer

Los Angeles, California

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2d ago

Position: Process Validation EngineerLocation: Northridge, CA-On SiteDuration: 12+ Months Contract Key ResponsibilitiesDevelop and execute IQ/OQ/PQ protocols for critical manufacturing processes.Conduct process characterization using DOE, SPC, and statistical modeling.Perform process capability studies (Cp/Cpk) and implement corrective actions for lowcapability processes.Define and maintain the Process Validation Master Plan (PVMP).Prepare validation protocols, reports, risk assessments, PFMEAs,

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Third Party, Contract

$60+

Validation Engineer

Boston, Massachusetts

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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

Validation Engineer

Round Lake, Illinois

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Today

Full-time

Equipment Engineer

Dallas, Texas

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Today

Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment. Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits. Establish preventive maintenance plans, calibration schedules, and critical spare parts lists. Author validation plans, validation protocols, test reports, inc

Full-time

Equipment Engineer

Minneapolis, Minnesota

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Today

Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment. Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits. Establish preventive maintenance plans, calibration schedules, and critical spare parts lists. uthor validation plans, validation protocols, test reports, includin

Full-time

Product Design Quality Engineer

Bothell, Washington

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Today

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Full-time

Product Design Quality Engineer

Cambridge, Massachusetts

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Today

Full-time

QUALITY ENGINEER

Hybrid in Chicago, Illinois

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2d ago

MAJOR RESPONSIBILITIES: Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files. Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Lead investigations of product and process non-conformances and out-of-specification results and develop ef

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Contract

Depends on Experience

Component Engineer

Irvine, California

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Today

Responsibilities: DVT & Design Release Support. Participate in DVT readiness and design reviews to identify component risks, manufacturability concerns, and documentation gaps. Support design transfer activities to ensure readiness for manufacturing release. Component Risk & Lifecycle Assessment Evaluate lifecycle status (NRND/EOL), supplier risk, and availability Recommend alternates and mitigation strategies. Support Release of OTS and custom parts Mechanical Drawing Review & Manufacturability

Full-time

Validation Engineer

Hybrid in Chicago, Illinois

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3d ago

QUALITY ENGINEER / QUALITY COMPLIANCE ENGINEER our client is looking to hire 15-20 people Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMRs, product specifications, design control files, and CE

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Contract

Depends on Experience

Quality Specialist

Missouri

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Today

Quality Specialist JD: Position Summary The Quality Specialist supports quality functions at STERIS's site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The role splits into two main functions: document control and product release. This is a desk-based position with no lab work required, though familiarity with lab paperwork is a plus. The Quality Specialist works closely with lab, manufacturing, and quality engin

Contract

$30.00 - $35.00

Lead Medical Device Product Lifecycle Engineer

Blue Ash, Ohio

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Today

Job Title: Senior Medical Device Quality & Validation Engineer Location: Blue Ash, OH Duration: 6 months Role Descriptions: 7+ years of engineering experience in medical device or other regulated industries. Experience leading cross-functional technical projects. Experience with component development, supplier qualification, design verification, and manufacturing validation. Strong understanding of design controls, change management, risk management, process validation, and quality system comp

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Third Party

$35

Verification & Validation Test Engineer

Marlborough, Massachusetts

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Today

IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life. Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retainin

Full-time

Engineer II, Design Quality (hybrid)

Southington, Connecticut

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Today

Job Description Position Summary Provide quality support for ICU Medical Consumable development. The Design Quality Engineer II will support activities such as CAPA investigations, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards. Essential Duties & Responsibilities Effectively utilize quality tools and processes such a

Full-time

Sr. Process & Operations Engineer

Minnetonka, Minnesota

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Today

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making bette

Full-time

USD 130,000.00 - 150,000.00 per year