Qms jobs in cambridge, ma

Boston, Massachusetts

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14d 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

Sr. Staff Engineer - Polymer Biomanufacturing

Woburn, Massachusetts

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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 The Sr. Staff Engineer, Polymer

Full-time

USD 161,400.00 - 258,200.00 per year

Senior Requirements Engineer

Cambridge, Massachusetts

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Today

Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our multidisciplinary teams of engineers and scientists work in a collaborative environment that inspires the cross-fertilization of ideas

Full-time

USD 82,300.00 per year

Requirements Engineer

Cambridge, Massachusetts

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Today

Full-time

USD 62,500.00 - 140,000.00 per year

Digital Engineering Developer

Cambridge, Massachusetts

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Today

Full-time

USD 75,000.00 - 156,000.00 per year

Sr. Electrical Engineer

Marlborough, Massachusetts

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Today

Job Description Job Summary: Driven by our purpose to enable healthier lives everywhere, every day, we are seeking a talented and experienced Electrical Engineer to join a growing R&D department in our Surgical Division to contribute to sustaining of both Capital and Disposable products. The Sr. Electrical Engineer, Product Engineering, delivers value by ensuring all capital products continue to meet the needs of both customers and the business throughout their lifecycle. Our team is customer

Full-time

USD 97,600.00 - 152,700.00 per year

Quality Engineer

Marlborough, Massachusetts

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Today

Location: Marlborough, MA Salary: $75,000.00 USD Annually - $99,000.00 USD Annually Description: Quality Engineer Job Summary The Quality Engineer supports product quality and reliability across Systems products by applying established quality engineering principles and practices. This role partners with Engineering, Manufacturing, Supply Chain, and Operations to ensure product quality, process capability, and compliance throughout the product lifecycle. Working under general supervision, th

Contract

USD 75,000.00 - 99,000.00 per year

Human Factors Engineer 4

Marlborough, Massachusetts

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Today

Job Description Job Summary: Lead Human Factors Engineer possessing deep expertise in human factors engineering, usability engineering, and user-centered design to support and lead the development of safe, effective, and intuitive medical devices from concept through commercialization. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs. T

Full-time

USD 128,200.00 - 200,500.00 per year

Director IT, Integration & Middleware

Marlborough, Massachusetts

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Today

Job Description Why Hologic? At Hologic, we're passionate about advancing women's health through innovative medical technologies that detect, diagnose, and treat disease with greater accuracy and confidence. Every day, our teams help improve lives worldwide through groundbreaking solutions in diagnostics, breast and skeletal health, and gynecologic surgery. We are seeking a strategic and experienced Director, Integration & Middleware to lead the vision, architecture, and delivery of enterpris

Full-time

USD 175,000.00 - 250,100.00 per year

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

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Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

Easy Apply

Contract

Quality Assurance Engineer Manager

Bedford, Massachusetts

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Today

Description Cloud One Next (C1N) provides secure, scalable cloud landing zones for Mission System Owners (MSOs) across the Department of Defense (DoD), supporting both cloud-native operations and migration from on-premises environments. C1N delivers standardized services across multiple Defense Information Systems Agency (DISA)-approved Cloud Service Providers (CSPs) for Impact Levels (IL) 2, 4, 5, and 6, along with consistent guardrails, tools, and Day-2 operational support for Department of t

Full-time

USD 92,300.00 - 166,850.00 per year

Senior Data Standards Analyst

Marlborough, Massachusetts

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Today

Additional Location(s): US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing -

Full-time

USD 89,200.00 - 169,500.00 per year

Lifecycle Engineer

Remote

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30+d ago

Job Title: Lifecycle Engineer Job Category: Engineering Time Type: Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel Required: Up to 100% Type of Travel: Continental US * * * Military Sealift Command (MSC) operates ships for the Armed Forces and other agencies. These ships are operated by US Coast Guard (USCG) licensed Merchant Mariners and maintained to commercial standards. Ships are both Government Owned-Government Operated (GOGO) or Gov

Full-time

USD 63,300.00 - 129,700.00 per year

Lifecycle Engineer - RPC

Remote

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Today

Job Title: Lifecycle Engineer - RPC Job Category: Engineering Time Type: Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel Required: Up to 10% Type of Travel: Continental US * * * Military Sealift Command (MSC) operates ships for the Armed Forces and other agencies. These ships are operated by US Coast Guard (USCG) licensed Merchant Mariners and maintained to commercial standards. Ships are both Government Owned-Government Operated (GOGO) o

Full-time

USD 63,300.00 - 129,700.00 per year

Technical Project Manager - SaMD / GxP Validation

Remote

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Today

Technical Project Manager - SaMD / GxP Validation. We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS). This is a technology role, not clinical operations, and we want someone who can start delivering in week one. Engagement 12-month contract

Contract

$60.00 - $80.00

Technical Project/Program Management - Technical Program Manager V

Remote

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Today

Job#: 3053591 Job Description: Technical Project/Program Management - Technical Program Manager V Compensation: $12- - $130 hourly Location: Remote, California (Remote) Role Overview We are seeking a senior Technical Program Manager with relevant Software as a Medical Device (SaMD) experience. This role focuses on managing the software release process for a key medical device feature. The position requires leading cross-functional teams to ensure deliverables are completed in accordance wit

Easy Apply

Full-time

$120 - $130 per hour

Industrial Engineer - 1st Shift - Travel

Remote or Texas

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Yesterday

Logistics at full potential. At GXO, we're constantly looking for talented individuals at all levels who can deliver the caliber of service our company requires. You know that a positive work environment creates happy employees, which boosts productivity and dedication. On our team, you'll have the support to excel at work and the resources to build a career you can be proud of. 1st Shift, Monday - Friday, 8:00am - 5:00pm As the Industrial Engineer you will be responsible for identifying facil

Full-time

GxP Systems and Support Administrator

Remote

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Senior Solution Architect (Remote - USA)

Remote or Atlanta, Georgia

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6d ago

Tasks Tasks Tasks The Role As a Senior Solution Architect, you will leverage your deep expertise in engineering, manufacturing, design, and quality to define, guide, and implement complex solutions across IT, process, and organizational transformation initiatives. You will act as a strategic technical leader, working hands-on to architect scalable and practical solutions that meet client objectives and integrate seamlessly within their operational frameworks. You bring a strong record of success

Full-time

USD 125,000.00 - 165,000.00 per year

Sr. Computer Systems Validation Engineer

Remote or Trumbull, Connecticut

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Today

Job Description Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in

Full-time

USD 96,441.00 - 126,000.00 per year

Qms jobs in Cambridge, MA, USA