- Assist and coach the engineering team with improving and maintaining the Quality Management System (QMS) to comply with industry regulations.
- Guidance on best practices for design controls, oversee the risk management process and analysis, and plan out Verification & Validation efforts (V&V) for combination medical devices.
- Help maintain all quality documentation related to products, including product test protocols, change management and notification processes, corrective and preventative actions (CAPA), customer complaints, audits, and related items.
- Review and consolidate product requirements for medical device systems according to applicable regulations.
- Train and coach teams to use, follow, and work under QA Processes along the projects.
- At least 5 years of experience developing and maintaining a quality management system (QMS) that complies with ISO 13485 and/or 21 CFR part 820.
- Experience with passing electromechanical systems through IEC 60601 certification.
- Organized and coordinated Verification & Validation efforts (V&V) for medical devices.
- Trained engineering staff on best practices for design controls pre and post-launch.
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Quality Manager
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Fagron GmbH & CO. KG Boston, United StatesVoor onze locatie in Uitgeest zijn wij op zoek naar een: · Waarborgen van de kwaliteit van grondstoffen, verpakkingen, het productieproces en de bewaarcondities. Goedkeuren, afkeuren of uit de handel nemen van producten en grondstoffen. · Verantwoordelijkheidsgebieden en kerntake ...
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Ajsearch Boston, United StatesJob Description · Responsible for collaborating with internal business partners to review and solidify quality systems and quality metrics, while identifying specific areas of opportunity to provide world class service to customers. Identify gaps in quality processes, training o ...
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Veritas Search Group Boston, United StatesSenior Manager, Quality Assurance (Med Device / Combination Products) · Do you have the right skills and experience for this role Read on to find out, and make your application. · Location: Fully Remote · Scope of Work: · The Senior Manager, Quality Assurance (Med Device / Co ...
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Quality Control Manager
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Katalyst HealthCares & Life Sciences Boston, United StatesResponsibilities: · Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control and preventative activities. · Supports the development and introduction of new products, processes, and technologies, with ...
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Quality Management Coordinator
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Interwell Health Boston, United StatesThe Coordinator, Quality Management position will assist with processes and initiativesaimed at meeting various quality measures included in the companys value-based contracts.The work you will do :Review data elements and documentation for accuracy and potential for inclusion to ...
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Shawmut Boston, United StatesOverview: · Since our founding in 1982, Shawmut Design and Construction (a 100% employee-owned company) has been recognized as a Best Place to Work 70 times by our employee-owners. At Shawmut, you will have the opportunity to own your career and deliver impact within our culture ...
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Quality Management Coordinator
2 days ago
Interwell Health Boston, United StatesThe Coordinator, Quality Management position will assist with processes and initiatives · aimed at meeting various quality measures included in the company's value-based contracts. · The work you will do : · Review data elements and documentation for accuracy and potential for ...
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Quality Assurance Manager
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RADCUBE | Rapid Technology Solutions Boston, United StatesPrimary Responsibilities · • Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · • Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. · • Identify systemic p ...
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Cerevel Therapeutics Boston, United StatesRole Summary:The Sr. Manager, Quality Management (GLP) is an important liaison with the Safety Assessment, Clinical Pharmacology, and DMPK teams. Specifically, the Sr. Manager, Quality Management (GLP) applies working knowledge in pharmaceutical research and quality assurance to ...
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Quality Manager
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Keolis Commuter Services Boston, United States** Quality Manager - Service Delivery** · **Job Category****:** Operations Management · **Requisition Number****:** QUALI01456 · Showing 1 location · **Role Title:** Quality Manager, Service Delivery · * · Bachelors degree in Engineering preferred. · * · Excellent knowledge ...
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Eyebot Boston, United StatesAbout Eyebot: Eyebot is a deep tech company operating at the forefront of innovation in the vision care industry. We specialize in the development of self-serve, rapid vision exam technologies that deliver reliable results in a matter of seconds. Our mission is to eliminate the b ...
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Eyebot Boston, United StatesAbout Eyebot: Eyebot is a deep tech company operating at the forefront of innovation in the vision care industry. We specialize in the development of self-serve, rapid vision exam technologies that deliver reliable results in a matter of seconds. Our mission is to eliminate the b ...
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NavitsPartners Boston, United StatesJob Description · Job Description · Position: · Quality Assurance Test Manager · Duration: · 18-24 months · Hours Per Week: · 37.5 · Location: · Hybrid (Boston, MA) · Position Summary: · The QA Test Manager plays a critical role in ensuring the quality and compliance of the ...
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MatchPoint Solutions Boston, United StatesJob Description · Job Description · Position Title: Quality Assurance test Manager · Location: Boston MA - Hybrid Position · Duration: One Year Plus · Hours Per Week · Rate : $60/hr C2C · Client state of MA · Position Summary · The BEST QA Test Manager plays a critical role ...
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Dice Boston, United StatesDice is the leading career destination for tech experts at every stage of their careers. Our client, Motion Recruitment Partners, LLC, is seeking the following. Apply via Dice today · Our Client, an independent agency who oversee financial systems as well as manage external sing ...
Quality Manager - Boston, United States - Eyebot
3 weeks ago
Description
About Eyebot:Eyebot is a deep tech company operating at the forefront of innovation in the vision care industry. We specialize in the development of self-serve, rapid vision exam technologies that deliver reliable results in a matter of seconds. Our mission is to eliminate the barriers to affordable vision care and eyewear, by transforming a process that traditionally takes weeks or months into a matter of mere seconds.
Our interdisciplinary team harnesses the power of cutting-edge robotics, AI, and machine learning to create groundbreaking user experiences that work for everyone, at the touch of a button. Eyebot's mission is to revolutionize and disrupt the global vision care and eyeglass retail industry, making quality vision care accessible to everyone, equally, regardless of age, gender, race, or socioeconomic status.
Eyebot is backed by leading deep tech VCs and the prestigious National Science Foundation. Our headquarters are located near the North End waterfront in Boston.
Job Description:If you're excited about reshaping vision care, send your resume and portfolio to
Eyebot values and celebrates a diverse, inclusive workplace and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual's age, race, ethnicity, national origin, religion, gender, sexual orientation, disability, medical history, and any other basis protected by federal, state, or local laws. If you require accommodations to complete the hiring process please email us at