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Quality Assurance Specialist
26 minutes ago
Element Materials Technology Acton, United StatesOverview: · Element Materials Technology Boston-Acton, Inc. is looking for a full-time **Quality Assurance Specialist** to support the Quality Assurance Unit in a cGMP Microbiology Laboratory · **Responsibilities**: · - Comply with current Good Manufacturing Practice regulations, ...
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Quality Assurance Specialist
1 week ago
DPS Group Boston, United StatesADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...
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Quality Assurance Specialist
2 days ago
Axiomtek Methuen, United States**JOB BRIEF** · The position QA Specialist manages and maintains the database for the quality management system, prepares and presents quality trending reports, provides input to QA Manager and/or Team Leader on team member performance, maintains quality assurance documents and c ...
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Quality Assurance Manager
1 week ago
DV Die Cutting Inc. Danvers, United States**Overview**: · **Duties**: · - Develop and implement quality assurance policies and procedures · - Maintain ISO documentation · - Conduct regular quality audits to identify areas for improvement · - Oversee quality control processes, including QA/QC inspections · - Collaborate w ...
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Quality Assurance Specialist
1 week ago
DPS Group TSO Boston, United States**Summary** · ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk asses ...
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Quality Assurance Coordinator
1 week ago
MES Solutions, Inc. Norwood, United StatesOverview: · Are you a Medical Scribe who prides yourself on your strong writing/grammar abilities? Are you also looking to step away from a medical office and into a work-from-home position? · If you answered yes, then this might be the job for you because **MES **is looking for ...
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Quality Assurance Technician
1 week ago
Ultra Electronics Braintree, United StatesUnleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies. · Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldw ...
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Manager, Quality Assurance Operations
1 week ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
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Quality Assurance Test Manager
1 week ago
NavitsPartners Cambridge, United States**Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...
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Director of Quality Assurance
4 days ago
BrightHire Search Partners Burlington, United StatesDirector of Quality Assurance · We are seeking a Director of Quality Assurance to lead the quality systems for a revolutionizing medical device company that is changing the world of imaging. This is an opportunity to plan, direct, implement, and maintain quality assurance standar ...
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Manager, Clinical Quality Assurance
2 weeks ago
Lantheus Bedford, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.La ...
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Manager, Clinical Quality Assurance
1 week ago
Lantheus Bedford, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
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Manager, Clinical Quality Assurance
5 days ago
Lantheus Bedford, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
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Manager, Clinical Quality Assurance
1 week ago
Lantheus Bedford, United States· Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. · For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfo ...
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Manager, Clinical Quality Assurance
1 week ago
Lantheus Bedford, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.La ...
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Director, CMC Quality Assurance
1 week ago
Ultragenyx Pharmaceuticals Inc. Bedford, United StatesPosition Summary: · ultraimpact - Make a difference for those who need it most · The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality ...
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Manager, Clinical Quality Assurance
1 day ago
Lantheus Bedford, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
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Manager, Clinical Quality Assurance
10 hours ago
Lantheus Holdings, Inc. Bedford, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. · ...
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Quality Assurance Manager
1 week ago
EPM Scientific Billerica, United StatesTitle: Quality Assurance Manager (Medical Device) · Location: Billerica, MA · A pharma/med device company is seeking a Quality Manager to spearhead Quality activities related to their combination products. The Quality Manager will be responsible for all aspects of QA for medica ...
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quality assurance associate
1 week ago
Randstad Billerica, United Statesquality assurance associate. · billerica , massachusetts · posted today · job details · summary · $24 per hour · temporary · category production occupations · reference · job details · Position: Quality Inspector Location: Billerica MA Job Type: Full-time (6 Month contract, ...
Head of Regulatory Affairs and Quality Assurance - Bedford, United States - Genabio Diagnostics
1 week ago
Description
Position Overview:
The employee works with the management team to
• Oversee quality and legislative requirements of all products and services
• Work with contractors and regulatory agencies for product approval and life cycle management
• Manage regulatory and technical team
Required Education, Skills and Experience:
• Minimum of a bachelor's degree in a life scientific field such as Biochemistry, Biotechnology, Pharmacy, Medicinal chemistry, or Biomedical science
• Minimum of 5 years of experience in a similar role
• Excellent verbal and written communication skills
• Strong problem-solving skills
• Highly developed attention to detail
• Strong project management skills
• Proficiency in Chinese
Essential Functions/Responsibilities
Regulatory Affairs:
• Ensuring products in compliance with 510K regulations set by the Regulatory Agency
• Composing product, scientific and legal documents
• Working with others in the company on various products for technical and regulatory related matters
• Planning, undertaking and overseeing 510K clinical trials and FDA regulatory inspections
• Keeping up to date with changes in regulatory legislation and guidelines
• Obtaining marketing permission
• Liaising and negotiating with regulatory authorities
• Providing advice about regulations to manufacturers/scientists
• Ensuring that quality standards are met, and submissions meet strict deadlines