21 CFR Part 820 jobs in Remote

R&D Program Manager- MMS Project Management

San Diego, California

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17d ago

Position Title: R&D Program Manager MMS Project Management Location: Onsite San Diego, CA preferred, but will also entertain Remote options Start Date: ASAP Length of Contract: 6 months + extension Interview Process: 1st round on Teams with hiring manager for 30-45 minutes, 2nd round will consist of 2-3 other team leads. Background Check Required Scope: This Program Manager will lead a cross-functional Core Team through a critical compliance program to achieve full certification for medical elec

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Contract

$60 - $75

Supplier Manufacturing Engineer

Sunnyvale, California

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Today

Primary Function of Position: The ideal Candidate has a track record of supporting new products launch, demonstrated collaboration with Contract Manufacturers, and preferred experience with multiple manufacturing methods, including various metal/plastics machining processes, treatments, and finishing processes. Plastic Injection Molding and Metal Injection Molding are preferred as well. The candidate also has skills in selecting and developing suppliers. Roles & Responsibilities:

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Third Party, Contract

$70 - $77

Quality Senior Engineer

Englewood, Colorado

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Today

Job Title: Quality Senior Engineer I Work Location: Englewood, CO 80112 Duration: 11Months Job Type: Temporary Assignment Work Type: Onsite Job DescriptionReview, remediate, and migrate legacy CAPA records into EtQ to ensure completeness, accuracy, and compliance with global procedures.Manage assigned CAPAs through initiation, investigation support, action tracking, effectiveness verification, and closure.Perform gap assessments of CAPA records and support correction of documentation deficienci

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Contract

48 - 52

Component Engineer 4

Mountain View, California

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24d ago

Description: The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier engineer is responsible for ensuring suppliers meet ISI requirements for product quality, cost, and service. Roles and Responsibilities: Part Qualification Support Value Engineering and Quality Improvement Part Qualification efforts Lead Core Product Teams in defining appropria

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Third Party, Contract

$94 - $94

Sr. Product Development Engineer

Providence, Rhode Island

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Today

Roles & Responsibilities : uthor and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF). Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle. Support product development and technology transfer from early development through clinical and commercial manufacturing. Translate user needs into functional requirements and design outputs, including support of Human Factors Engineer

Full-time

Sr. Product Development Engineer

Boston, Massachusetts

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Today

Full-time

Product Development Engineer

Boston, Massachusetts

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Today

Job Summary: Senior Product Development Engineer to support the design and development of drug-device and biologic-device combination products for a fast-growing biotechnology company. The role focuses on drug delivery systems, design controls, and end-to-end product lifecycle support in a regulated environment. This is an onsite role based in the Boston, MA or Providence, RI area. Roles & Responsibilities: Author and maintain design control documentation, including Design History Files (DHF).

Full-time

Quality Senior Engineer I

Englewood, Colorado

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Today

IDR is seeking a Quality Senior Engineer I to join one of our top clients for an opportunity in Englewood, CO. This role involves supporting CAPA remediation and quality system compliance activities within a regulated medical device environment. The company is a leader in medical device manufacturing, emphasizing quality assurance and compliance. Position Overview for the Quality Senior Engineer I: Support CAPA remediation and quality system compliance activities within the QARA organization.Re

Full-time

Sustaining Engineering Project Manager (Medical Device)

Covington, Georgia

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18d ago

The Project Manager will lead and manage Sustaining Engineering projects for AcuteCare, HomeCare, and DryDoc product lines. This role involves planning, coordinating, and executing engineering changes, compliance activities, and product lifecycle management in alignment with quality systems. The Project Manager will work closely with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure timely delivery of project objectives. Key Responsibilities: Develop and manage project

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Contract, Third Party

45 - 50

Lab Equipment Validation Engineer

Rensselaer, New York

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9d ago

Lab Equipment Validation Engineer. Location: Rensselaer, NY Duration: 18 months The right candidate will be responsible for leading validation activities for laboratory equipment supporting infusion system testing in a regulated medical device environment, ensuring compliance with FDA regulations, ISO standards, and quality system requirements. Roles & Responsibilities: Lead validation efforts for laboratory equipments Develop and execute validation protocols, test plans, and reports in alignmen

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Contract

Depends on Experience

Medical Device Development Engineer

Addison, Texas

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27d ago

TheStaff Product Development Engineer drives product development from concept to commercialization including research, planning, concept creation, specifications, testing, validation, and communication with teams, management, and customers. Duties/Responsibilities Mentor and/or supervise engineers and designers across multiple projects.Collaborate with department leaders to shape corporate and technical strategy.Build and manage relationships with external design resources, KOLs, and surgeons.D

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Full-time

130000 - 160000

Quality Technician

Acton, Massachusetts

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Today

Advantage Technical is hiring a Quality Technician for a cutting-edge medical device manufacturer in Acton, MA. This is a rare opportunity to contribute to U.S. manufacturing expansion at a company investing heavily in innovation, people, and product development. Schedule: Day Shift | Cleanroom environment | Occasional lifting up to 20 lbs What You'll Do Perform incoming, in-process, and final inspections on raw materials, WIP, and finished goods Generate and maintain quality records - NCRs, CA

Full-time

Quality Engineer (Medical Device, Pharmaceutical)

Hybrid in Denver, Colorado

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Today

Please note I have direct access to the Hiring Director on this position. Compensation: Base Salary + Bonus: 10% + Relocation Assistance We are the leading Global Biotech Company in our niche and are looking for a Quality Engineer. We have been in business for 50+ years, are publicly traded, have 7+K global employees, recognized $6.6 billion in revenues (7% increase over previous year), $153 million in profits (32% increase over previous year), have 750+ product patents, released 6 new products

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Full-time

$140,000 - $150,000

Test Validation Engineer

San Diego, California

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Today

Description: Onsite in San Diego, CA Our client seeks a Test Validation Engineer to lead software verification and validation for regulated medical device manufacturing systems. The role focuses on translating user needs into testable requirements, authoring protocols, executing system-level testing, and producing compliant V&V documentation. Experience with 21 CFR Part 820, measurement systems analysis using JMP, and LabVIEW in NI-based test environments will support success. The engagement i

Contract

Sr Engineer Software Validation

Redmond, Oregon

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Today

Job Summary Job Description JOB SUMMARY Deliver leadership-level role in the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner. MAJOR RESPONSIBILITIES Evaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related validations.Ensure scope and complexity of validations are commensurate with risk including the des

Full-time

USD 101,000.00 - 152,000.00 per year

CSV Engineer

Newark, Delaware

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Today

Job Summary: We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle. Roles & Responsibilities: Lead and support CSV activities for GxP systems, in

Full-time

Sr Engineer II, Algorithm (ECG)

Irvine, California

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Today

Job Description Job Summary: The Senior Engineer II, Algorithm (ECG) is a senior-level individual contributor responsible for architecting, developing, validating, and optimizing advanced ECG-based signal processing algorithms for Masimo's non-invasive medical device platforms. This role provides technical leadership in the design and deployment of robust, real-time cardiac monitoring algorithms across the full product lifecycle - from early feasibility and system architecture through embedde

Full-time

USD 139,000.00 - 185,000.00 per year

Senior Manager, R&D Software Engineering

Remote or Milpitas, California

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Today

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

Full-time

USD 157,000.00 - 271,400.00 per year

Med Device Auditor

Remote

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7d ago

Job SummaryWe are seeking an experienced and detail-oriented Medical Device Auditor to evaluate and ensure compliance with medical device quality systems, regulatory requirements, and industry standards. The ideal candidate will conduct audits of manufacturing processes, quality management systems, supplier controls, and documentation practices to ensure compliance with FDA, ISO 13485, MDR, and other applicable regulations. The candidate should possess strong analytical skills, deep understandin

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Contract

Depends on Experience

Sr. Packaging Process Engineer

Fort Myers, Florida

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Today

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better . We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insura

Full-time

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21 CFR Part 820 jobs in Remote