21 CFR Part 820 jobs

Reedsville, Pennsylvania

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23d ago

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments. Key Resp

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Contract, Third Party

55 - 60

COMPONENT ENGINEER 3

Sunnyvale, California

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Today

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

Component Engineer 4

Sunnyvale, California

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Today

Description: WOW: Minimum 3 Days onsite Job Title: Contingent Supplier Engineer MP Systems Department: Supplier Engineering Reports to: Sr Manager, Supplier Engineering Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority. Primary Function of Position: The mission of Supplie

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Third Party, Contract

$93 - $93

Quality engineer / Lead/ Manager - Medical Devices Manufacturing Experience

Reedsville, Pennsylvania

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22d ago

Role: Quality engineer / Lead/ Manager Medical Devices Manufacturing Experience Positions: 5 Openings Location: Reedsville, PA (Day 1 Onsite) Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield

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Contract, Third Party

Depends on Experience

Project Manager – Medical Device Manufacturing Transfer

Arvada, Colorado

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Yesterday

Skills Required: Program management, manufacturing transfer, medical device compliance, ISO 13485, FDA 21 CFR Part 820, EU MDR, GMP, IQ/OQ/PQ, process validation, risk management, and Microsoft Project. Experience: Strong leadership in medical device manufacturing transfers, preferably sterile disposable devices. Must manage cross-functional teams, BOMs, process documentation, supply continuity, validation, budgets, risks, and executive reporting. PMP, Lean Manufacturing, and Six Sigma are prefe

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Full-time

35 - 40

CSV Validation Engineer

Boston, Massachusetts

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13d ago

Job Summary We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk Roles & Responsibilities Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards. Perfo

Full-time

Quality Engineer

Hybrid in Phoenix, Arizona

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21d ago

Quality Engineer Phoenix, AZ We are seeking a Quality Engineer to support quality and compliance activities within pharmaceutical, biotechnology, and medical device manufacturing environments. The Quality Engineer will work with cross-functional teams to identify quality issues, investigate root causes, implement corrective actions, and support continuous improvement initiatives. Key Responsibilities Support quality assurance and quality control activities in manufacturing environments.Investiga

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Contract

Depends on Experience

Validation Engineer

Boston, Massachusetts

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13d ago

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

Engineering Manager

Danvers, Massachusetts

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Today

We anticipate the application window for this opening will close on - 19 Nov 2026 Position Description: Engineering Manager for Medtronic, Inc. in Danvers, MA. Plan, direct and implement various aspects of the design and development of new medical device products. Develop, evaluate, implement and maintain technical quality assurance and control systems standards in extrusion and assembly manufacturing pertaining to materials, techniques, and products. Select, develop and evaluate personnel to e

Full-time

USD 178,000.00 - 213,000.00 per year

Quality Control Inspector

Tigard, Oregon

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Today

Job Title: Quality Control Inspector Location: 16125 SW 72nd Ave, Portland, OR 97224 Duration: 12 months Work Arrangement: 100% Onsite Shift: 7:00 AM ? 3:30 PM Pay Range: $25 - $28 per hour (W2) We are seeking a ?Quality Control Inspector? to join one of our leading healthcare clients. Description The Inspector performs basic routine inspection of electronic, electro-mechanical and/or mechanical materials, components and sub-assemblies received, in process of manufacture, or manufactured,

Full-time

Compensation information provided in the description

Analyst, Product Surveillance

Plymouth, Minnesota

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Today

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address can be reached on # . We have Contract role Analyst, Product Surveillance for client at Plymouth, MN. Please let me know if you or any of your friends would be interested in this position. Position Details: Analyst, Product Surveillance- Plymouth, MN Location : Plymouth, MN 55442 (100% Onsite) Project Duration : 4-6 Months of contract Shift Timing : 8:00 AM to 4:3

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Contract

$30.5

Principal Engineer, Software Quality

Bonita, California

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Today

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description As the Principal Engineer in So

Full-time

USD 129,600.00 - 207,400.00 per year

Global Regulatory Affairs and Compliance Manager- Medical Devices

Albuquerque, New Mexico

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Today

How will you make an impact?The Regulatory Affairs & Compliance Manager is responsible for developing, implementing, and maintaining regulatory affairs and quality system compliance programs to ensure continued compliance with applicable global regulations, standards, internal and customer requirements. This position provides regulatory affairs leadership and compliance oversight across manufacturing operations, supports regulatory inspections and external audits, and partners with cross-functio

Full-time

Senior Engineer, Quality Assurance

Portage, Michigan

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Today

Work Flexibility: Hybrid Senior Quality Assurance Engineer Redmond, WA or Portage, MI Join a team where your expertise directly impacts patient safety and product performance. As a Senior Quality Assurance Engineer, you'll lead Emergency Care critical investigations and drive improvements that shape the future of medical technology. This is a high-impact role for someone passionate about solving complex problems and ensuring quality excellence across the product lifecycle. Work Flexibility:

Full-time

USD 69,500.00 - 110,900.00 per year

Director, Software Engineering

San Diego, California

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Today

At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness. We're hiring a Director of Software Engineering to lead a team of developers

Full-time

USD 180,000.00 - 254,000.00 per year

Sr. Process & Operations Engineer

Boston, Massachusetts

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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

Sr. Process & Operations Engineer - Menlo Park, CA

Menlo Park, California

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Today

Full-time

Professional - Engineering - Quality Operations Specialist I

California

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Today

Professional - Engineering - Quality Operations Specialist I - Contract - Irvine, CA - $40.00 - $42.96/hr The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not

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Contract

USD 40.00 - 42.96 per hour

Senior Chemical Engineer

Woburn, Massachusetts

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Today

Position Summary This position will play a key leadership role in the design, development, and optimization of industrial processes to turn raw materials into valuable products. You will combine your expertise in photolithography, acid chemistry, and metallurgy to deliver burr-free, stress-free micro-features that meet the stringent dimensional and biological requirements of life-critical medical devices. This role will include working with the operations, scheduling, customer service, and qual

Full-time

Engineer II, Design Quality (Hybrid - San Clemente, CA)

San Clemente, California

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Today

Job Description Position Summary Provide quality support for ICU Medical Consumables development. The Quality Engineer will support activities such as CAPA investigations, Post Market Risk Assessments, 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

Full-time

USD 71,250.00 - 102,125.00 per year