- Serve as the QSR/ISO management representative
- Work with the FDA, and California State Department of Health during company inspections
- Certify adverse event fillings to foreign regulatory authorities are aligned with company policies and foreign regulatory requirements.
- Hire, develop, and mentor a team of Quality Engineers
- Work with cross-functional teams to ensure compliance is being met on all levels.
- Implement and maintain compliance with QSR and ISO 13485
- Develop and lead programs for best practices for compliance and quality assurance.
- Design control activities and work with the design engineering team on risk management for new product features.
- Develop and implement the Quality Department budget, schedules, objectives, training plans, and performance reviews.
- B.S. in life sciences, engineering, or equivalent experience required.
- 5+ years of management experience
- Experience working with an Electromechanical Medical Device
- 10+ years of related experience in the Class II, and Class III medical device industry.
- Proficient in 21CFR 820 and the Medical Device Directive
- Solid knowledge of FDA Quality System requirements, ISO Quality System) requirements, ISO Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP), and applicable Quality System Standards
- Experience with ISO 62304, Medical Device Software - Software Life Cycle processes
- Familiar with EN 60601, Safety requirements for medical electrical systems
- ISO 13485 Lead Auditor training
- Ability to analyze and interpret standards, technical procedures, professional journals, and governmental guidance and regulation documents.
- Experience with manufacturing or product development is a huge plus
- Direct interaction with FDA reviewers/inspectors
- Working knowledge of MDR/ Vigilance Reporting
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Quality Assurance
1 week ago
Global Pharma Woburn, United States**Title: Quality Assurance** · **Location: Woburn, MA** · **Duration: 09 Months** · Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which ...
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Quality Assurance Specialist
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Deephealth Somerville, United States**Job Description**: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet's succ ...
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Quality Assurance Specialist
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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
3 weeks 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
3 weeks 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 Manager
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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
2 weeks 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 Coordinator
3 weeks 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
3 weeks 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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Quality Assurance Lead
4 days ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
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Quality Assurance Manager
7 hours ago
RADcube Boston, United States**Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...
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Quality Assurance Lead
2 days ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
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Quality Assurance Specialist
1 week ago
Randstad Life Sciences US Burlington, United StatesSpecialist, QA · 6 Months- likely to go much longer · Burlington, MA · Hourly pay $45.00 · Day shift Mon-Fri, 8 hour shift, or Wed-Sat hr our shifts) · Job Summary · In this role, you will support Quality On The Floor (OTF) oversight of manufacturing activities and Facili ...
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Manager, Quality Assurance Operations
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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 Specialist
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Randstad Life Sciences US Burlington, United States6 Month Contract · Burlington, MA · PR: $35-45/hour · Mon-Fri, 8 hour shifts · OR · Wed-Sat 7am-5pm (4, 10 hour shifts) · Job Summary · In this role, you will support Quality On The Floor (OTF) oversight of manufacturing activities and Facilities. This position will be based in ...
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Quality Assurance Test Manager
3 weeks 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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IT Quality Assurance Analyst
1 week ago
EG America LLC Westborough, United States**Position Summary**:The IT QA Analyst is a supporting role to Application Management and Technology services efforts within the IT department. The IT QA Analyst will be responsible for the testing and certification of new releases of software to the existing production environme ...
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Specialist, Quality Assurance
2 days ago
Moderna Norwood, United States**The Role**: · The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc. · **Here's What You'll Do**: · Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or es ...
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Manufacturing Quality Assurance
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TalentBurst Woburn, United StatesTitle: Manufacturing Quality Assurance · Location: Woburn, MA · Duration: 12+ Months · Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform ...
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Functional Quality Assurance Manager
1 week ago
Lockheed Martin Chelmsford, United States**Job ID**: 661173BR · **Date posted**: Feb. 15, 2024 · **Program**: Functional · **Description**:Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members ...
Director of Quality Assurance - Burlington, United States - BrightHire Search Partners
Description
Director 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 standards to ensure the delivery of high-quality products.
Job Duties:
Qualifications:
