- Purchasing Process:
- Understand and improve purchasing process as it pertains to manufacturing. Whereas this connects to the Change Order process, it extends into the ERP and Salesforce.
- Understand and resolve existing pain-points, both through direct application of resource and through preventive process improvements
- Supplier Management Process:
- Re-establish Approved Supplier List and associated records
- Integrate Supplier Management Process with Purchasing and Change Order Processes
- Supply chain and incoming inspection
- Develop and implement supply chain process improvement
- Drive true root cause analyses in support of Nonconformance process, implement continuous improvement to product and process
- Lead and manage quality initiatives in multiple areas of product and processes quality. Ensure successful, on-time completion of continuous improvement projects,
- Escalate potential issues that could impact compliance, reliability, cost and quality.
- Perform other duties as assigned
- Establish and maintain approved supplier list.
- Administer and improve Quality processes, with focus on Lean process management
- Bachelor's degree (minimum) in an Engineering, Technical or Scientific discipline or equivalent.
- Pragmatic, entrepreneurial personality and strong self-starter. Always strives to improve
- Minimum of 2+ years of working experience in Quality Assurance in regulated (e.g. IVD, Medical Device, Automotive, etc.) environment.
- Deep understanding of purchasing and supplier management processes
- Understand Design Controls, Change Controls, Product, and Engineering Processes.
- Proficient in Statistical Process Controls & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
- Communicates effectively both verbally and in writing
- Acts decisively with Integrity and Kindness.
-
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 ...
-
Quality Assurance Specialist
1 week ago
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 ...
-
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 ...
-
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 ...
-
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 ...
-
Quality Assurance Lead
5 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, ...
-
Quality Assurance Lead
3 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, ...
-
Quality Assurance Manager
1 day 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 ...
-
Quality Assurance Manager
3 weeks 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 ...
-
Quality Assurance Specialist
2 weeks 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, ...
-
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 ...
-
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 ...
-
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 ...
-
Manager, Quality Assurance Operations
3 weeks 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 ...
-
Quality Assurance Testing Lead
1 week ago
Global Atlantic Financial Group Opportunities Boston, United States**COMPANY OVERVIEW** · Global Atlantic Financial Group is a leader in the U.S. life insurance and annuity industry, serving the needs of individuals and institutions. Global Atlantic is a wholly-owned subsidiary of KKR, a leading global investment firm that offers alternative ass ...
-
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 ...
-
Contract - Quality Assurance Specialist, Cmc
2 weeks ago
Vedanta Biosciences Cambridge, United States**Title: Contract - Quality Assurance Specialist, CMC** · **Location: Cambridge, MA and Acton, MA** · **Reports to: Supervisor, Quality Assurance** · **About Vedanta Biosciences**: · **The Role**: · The QA CMC Specialist is responsible for performing a wide variety of activities ...
-
Quality Assurance Specialist I
3 days ago
Catalent Chelsea, United States**We're hiring for a rotating night shift Quality Assurance Specialist I to provide QA support for cGMP manufacturing activities, at our facility in the Boston area** · Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ...
-
Specialist, Quality Assurance
3 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 ...
-
Director of Quality Assurance
2 weeks 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 ...
Manufacturing Quality Assurance - Woburn, United States - TalentBurst
Description
Title: Manufacturing Quality AssuranceLocation: 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 which is utilized in sample preparation processes in the analytical and life sciences industries worldwide.
Summary:
We are seeking a Quality Assurance Contractor to join our team for 9 t0 12 months. The Quality Assurance Contractor will play a key role in implementing an efficient ISO-13485 / IVDR compliant environment. Initial primary focus will be on supply chain related processes including purchasing, supplier controls, nonconformance and incoming inspection processes.
The Quality Engineer will report directly to the Director of QA/RA. High level of independent activity is expected. Position is majority of time on site.
Qualifications: