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Quality System Manager
1 week ago
BlackTree Technical Group, Inc. Sudbury, United StatesQuality Systems Manager · SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: · • Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements). · • Manage Document Contro ...
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Quality Management System Manager
4 weeks ago
Whitridge Associates Wayland, United StatesSUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: · Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. · Key opinion leader for the oversight over manufacturing of ass ...
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IT System Management Merchant
1 week ago
Omega Innovations Needham, United StatesJoin our Digital Journey at Needham · Joining forces with CANCOM means thinking customer-oriented and wanting to make a difference. With more than 5,600 employees, we work every day to improve various areas of life with the help of modern IT solutions. Are you interested in being ...
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Quality Systems Manager
1 week ago
Infinity Systems Institute, United StatesAbout the Company · Whether it's wiring systems, electromechanical systems, high-voltage or SCR systems: we stand for technology that serves progress and people. We know all about pole positions, for example when it comes to the mobility of tomorrow. Our goal: the winner's podium ...
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Quality System Manager
1 week ago
BlackTree Technical Group, Inc. Sudbury, United StatesQuality Systems Manager · SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: · Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements). · Manage Document Control ...
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SilverLinx Watertown, United StatesExpand our academic world throughout Germany at the location Bremen, Dresden, Cologne or Munich as a freelance lecturer (m/f/d) on a fee basis in the Dual Study Program with 50 teaching units starting . · What to expect · You independently prepare teaching sessions and conduct th ...
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Information Systems Security Manager
4 weeks ago
gTANGIBLE Corporation Hanscom Air Force Base, United StatesgTANGIBLE Corporation (gTC), , is a S corporation and a registered Government contractor that provides services and solutions in: · National Security Programs · Professional, Administrative, and Management Support · Mission and Warfighter Support · We are a Service Disabled Veter ...
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Manager, Quality Control Systems
3 weeks ago
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Control (QC) professional to join our team as Manager QC Syste ...
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Information System Security Manager
3 weeks ago
Fisheye Software Maynard, United StatesJob Description · Job DescriptionFishEye Software, headquartered in Maynard, MA, is a leader in developing, integrating, and testing mission-critical and operational software for both government and commercial sectors. With a focus on real-time and embedded systems, our work span ...
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Information Systems Security Manager
3 weeks ago
General Dynamics Information Technology Hanscom Air Force Base, United StatesInformation Systems Security Manager (ISSM) II · The ISSM's primary function serves as a principal advisor on all matters, technical and otherwise, involving the security of information systems under their purview. Primary support will be working within Special Access Programs (S ...
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Information System Manager
4 weeks ago
Atrius Health Watertown, United StatesAtrius Health, an innovative healthcare leader, delivers an effective system of connected care for more than 690,000 adult and pediatric patients at 30 medical practice locations in eastern Massachusetts. Atrius Health's 645 physicians and primary care providers, along with 420 a ...
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IT Systems Manager
1 week ago
Spindrift Newton, United StatesWe are looking for an IT Systems Manager based out of the Newton, MA office who will be responsible for directing the company's business systems operations. This includes evaluating, implementing, and providing ongoing support for enterprise business platforms including ERP, EDI, ...
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IT Systems Manager
1 week ago
Spindrift Newton, United StatesJob Description · Job DescriptionWe are looking for an IT Systems Manager based out of the Newton, MA office who will be responsible for directing the company's business systems operations. This includes evaluating, implementing, and providing ongoing support for enterprise busin ...
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Manager, Supplier Quality Systems
4 weeks ago
Insulet Corporation Acton, United States Full timeInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative ...
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Manager - Systems Engineering (Onsite)
4 days ago
Raytheon Careers Marlborough, United States Permanent, Full time*Date Posted:* *Country:*United States of America*Location:*MA801: Marlborough, MA 1001 Boston Post Road Building 2, Marlborough, MA, 01752 USA*Position Role Type:*Onsite*The Protected Communication Systems (PCS) Team is currently seeking a motivated Systems Engineering Manager w ...
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Manager, Quality Systems
2 days ago
Quest Diagnostics Marlborough, United StatesOverview: · Manage the quality management system and regulatory requirements for Quest Diagnostics to comply with all applicable regulations and standards including but not limited to FDA CFR Part 820 (QSR), ISO Quality Systems), ISO Risk Management), IVDR 2017/746 (In-Vitro Dia ...
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Employee in strategic sales
1 week ago
Spectrum Innovations Wayland, United StatesAbout the Company · At Wayland, you can make a big impact and confidently look towards the future. In our 90 years of history, we have evolved from a small manufacturing business to a full-service provider for vehicle and facility equipment. · What do we offer? · Enjoy a balance ...
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Specialist - System Management
3 weeks ago
ClifyX Framingham, United StatesJob Title: Specialist - System Management · Work Location: Framingham, MA · Job Description · OMS - experience is required in Sterling OMS and Java/Microservices experience is mandatory · Flexible to work in Shifts · Production support for OMS/INC Manangement/Problem Managme ...
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Director, Quality Management Systems
3 weeks ago
Apex Systems Cambridge, United States Full timeJob#: · Job Description: · Director, Quality Management Systems · Location: Boston,MA(Hybrid / Onsite) · Therapeutic Area: Small molecule Pharma · Job Overview: The role requires leading the development, design, and maintenance of the Quality Management System to ensure eff ...
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New Directions, IT & Digital Talent Solutions Waltham, United StatesJob Description · Job DescriptionSenior Principal Salesforce Business Systems Manager We are currently engaged in an executive search for a Senior Principal Salesforce Business Systems Manager. This role is with an international company who is a leader in their field. In this rol ...
Quality Management System Manager - Wayland, United States - Whitridge Associates
Description
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
Lead product and process improvement initiatives.Leads and maintains the development, completion, and maintenance of risk analyses.
Supports the generation and completion of protocols and reports for product, process, and test method validations.
Support the development implementation, and maintenance of defect categories.
Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.
Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications.Lead the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence.
Conducts complaint investigations and remediation recommendations as needed.Lead CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Conduct Supplier Audits and investigations as needed.Provide leadership and oversight for Supplier Qualifications process.
Leads the product transfers process and the construction of any Device History Files.
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