QMS Jobs in Massachusetts

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Quality Management Systems (QMS) and Cybersecurity Compliance Specialist

Dew Software

•

Massachusetts, USA

Contract, Third Party

Job Description: Seeking a skilled Quality Management Systems (QMS) and Cybersecurity Compliance Specialist to lead the integration and upgrade of our QMS, assist in internal cybersecurity audits, and provide regulatory submission support (FDA, EU) at our Boston site. The ideal candidate will bring a comprehensive understanding of quality management processes, document control, and corrective and preventive actions (CAPA), with experience supporting regulatory compliance initiatives. Key Respon
Easy Apply
Posted 60+ days ago | Updated 17 hours ago

Benchling Consultant

DRC Systems USA LLC

•

Remote

Contract

Overview: Looking for Benchling Consultant for REMOTE roleJob Description :We need someone to provide Benchling Application Support, candidate must have experience in providing technical support for Benchling application, addressing queries related to Benchling, ensuring a seamless user experience and compliance with QMS standards Experience in creating / updating Benchling templates, preparing training materials, automation using Python will be added advantage
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Posted 38 days ago | Updated 25 days ago

Sr. QA Manager

Zachary Piper Solutions, LLC

•

Chelmsford, Massachusetts, USA

Full-time

Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule. The Senior Quality Assurance Manager is pivotal in ensuring compliance with regulatory standards and driving continuous improvement initiatives. Responsibilities of the Senior Quality Assurance Manager include: Lead quality assurance for two products: balloon pump and balloon catheter. Develop and execute QA strategie
Posted 2 days ago | Updated 10 hours ago

Senior Quality Assurance Manager

Zachary Piper Solutions, LLC

•

Chelmsford, Massachusetts, USA

Full-time

Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule. The Senior Quality Assurance Manager is pivotal in ensuring compliance with regulatory standards and driving continuous improvement initiatives. Responsibilities of the Senior Quality Assurance Manager include: Lead quality assurance for two products: balloon pump and balloon catheter. Develop and execute QA strategie
Posted 2 days ago | Updated 10 hours ago

Solutions Porgram Manager

Gardner Resources Consulting, LLC

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Remote

Contract

Solutions Program Manager Required Skills and Competencies: SDLC and Infrastructure Program Management experience Agile/SAFe certification and transformation experience Project management certification preferred Experience leading development, testing, and launch of hardware, software, and cloud systems Experienced working with Agile teams to develop and launch strategic programs against concreate deadlines Knowledge of computer systems validation and QMS compliance Demonstrated flexibility and
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Posted 26 days ago

Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and Lifesciences

•

Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute
Posted 19 days ago | Updated 1 hour ago

Principal Product Security Engineer (REMOTE)

Stryker

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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
Posted 1 day ago | Updated 1 hour ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

•

Waltham, Massachusetts, USA

Full-time

Responsibilities: Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. V
Posted 19 days ago | Updated 1 hour ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 6 days ago | Updated 1 hour ago

Operational Excellence Engineer

Abbott Laboratories

•

Westford, Massachusetts, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 60+ days ago | Updated 4 hours ago

Quality Engineer

L3Harris Technologies

•

Northampton, Massachusetts, USA

Full-time

L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers' mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our culture is an unwavering focus on values, dedication to our communities, and commitment to excellence in everything we do. L3Harris Technologie
Posted 17 hours ago | Updated 13 hours ago

Senior Manager, Reliability Engineering

Analog Devices, Inc.

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Wilmington, Massachusetts, USA

Full-time

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI
Posted 45 days ago | Updated 1 hour ago

Senior Manager IT, Client Integration (Hybrid Opportunity)

Quest Diagnostics Inc.

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Remote or Secaucus, New Jersey, USA

Full-time

Overview Lead a variety of high-profile projects and teams to support Quest's Mergers and Acquisitions (M&A) growth opportunities with a focus on IT Client Connectivity solutions (EMR interfaces, LIS lab-to-lab interfaces, software implementation, etc.). Apply Quest Management System (QMS) principles and tools to drive projects to completion. Responsibilities Collaborate with Business Development, IT PMO, other internal departments and external entities to drive integrations for M&A.Persisten
Posted 26 days ago | Updated 1 hour ago

Senior MFG Eng - Network Projects

Johnson & Johnson

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Raynham, Massachusetts, USA

Full-time

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
Posted 1 day ago | Updated 1 hour ago

Cybersecurity & Application Specialist

Carrier Corporation

•

Beverly, Massachusetts, USA

Full-time

Country: United States of America Location: CAM60: Sensitech, Inc 800 Cummings Center, Beverly, MA, 01915 USA Carrier Global Corporation, global leader in intelligent climate and energy solutions, is committed to creating solutions that matter for people and our planet for generations to come. From the beginning, we've led in inventing new technologies and entirely new industries. Today, we continue to lead because we have a world-class, diverse workforce that puts the customer at the center o
Posted 9 days ago | Updated 1 hour ago

Manufacturing Engineer, Sustaining

Abbott Laboratories

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Westford, Massachusetts, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Job Title Manufacturing Engineer Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your
Posted 60+ days ago | Updated 4 hours ago

Associate Director, Engineering - Medical Device Combination Products (MDCP) Technical Lead

Merck & Company Inc

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Remote or Wilson, North Carolina, USA

Full-time

Job Description We are seeking a highly motivated individual for the role of Associate Director Engineering - MDCP Technical Lead, supporting the Wilson Packaging Technical Operations Team. This role will serve as the primary medical device and combination product (MDCP) point of contact for the site Packaging Technical Operations team. The MDCP Technical Lead will have responsibilities for supporting the design/tech transfer and sustainment activities of MDCPs at the Wilson site and ownership
Posted 9 days ago | Updated 1 hour ago

Sr Manager, Data Sciences

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest inve
Posted 58 days ago | Updated 1 hour ago

AI Engineer

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as an AI Engineer to implement innovative AI and ML methods for our GxP Quality Management System. Key Responsibilities: Build AI Solutions: Develop predictive models, anomaly detection systems, and LLMs to optimize QMS performance.Improve GenAI and LLMs: Apply Generative AI techniques and LLMs to automate and improve tasks like quality events analysis, document reviews, and complaint management.Work wit
Posted 60+ days ago | Updated 1 hour ago

Digital & IT Senior Analyst (Digital & Data Solutions)

Parker Hannifin

•

Woburn, Massachusetts, USA

Full-time

Org Marketing Statement PARKER CHOMERICS is a global supplier of EMI shielding, thermal interface materials, plastics and optical products. We offer a worldwide network of applications engineering support, manufacturing facilities, and sales offices. With stocking and fabrication on five continents, our products are available anytime, anywhere. With Headquarters in Woburn, MA, Parker Chomerics is part of a global Fortune 500 company but has a small company feel. We thrive on high performance tea
Posted 52 days ago | Updated 1 hour ago