Quality Assurance
2 weeks ago
**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 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.
- 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.
- 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
Continuous Improvement:
- 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
**Essential Responsibilities**:_The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity._
- Establish and maintain approved supplier list.
- Administer and improve Quality processes, with focus on Lean process management
**Non-Essential Responsibilities**:_The employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor._
**Qualifications**:
- 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.
**Job Types**: Full-time, Contract
Pay: $40.00 - $50.00 per hour
**Benefits**:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Work setting:
- In-person
Ability to Relocate:
- Woburn, MA 01801: Relocate before starting work (required)
Work Location: In person
-
Quality Engineer, Design Assurance
Found in: Talent US C2 - 2 weeks ago
Woburn, United States TalentBurst, Inc. Full timeTitle: Quality Engineer, Design AssuranceLocation: Woburn, MADuration: 12+ MonthsJob Summary: We are seeking a skilled Design Assurance Engineer or Systems Engineer to join our team as a contractor for a 9-12 month term. Reporting to the Director of QA/RA, the Quality Engineer, Design Assurance will establish and organize 21CFR820.30 compliant...
-
Senior Software Quality Assurance Engineers
5 days ago
Woburn, United States Randstad Digital Full timeSenior Software Quality Assurance Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop and execute test automation frameworks for handheld devices and software solutions. Conduct testing before product launches, review requirements and budget. Analyze defect, design, and technical documentation, and specifications, code,...
-
Design Assurance Engineer
Found in: beBee S US - 2 weeks ago
Woburn, United States Motion Recruitment Full timeOur client is a leading innovator in the healthcare industry, specializing in the development and production of cutting-edge medical devices. Their mission is to improve patient outcomes and quality of life through advanced technology and rigorous quality standards. They are seeking a highly skilled and detail-oriented Design Assurance Engineer to join...
-
Senior Software Quality Assurance Engineers
Found in: Jooble US O C2 - 5 days ago
Woburn, MA, United States Randstad Digital Full timeSenior Software Quality Assurance Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop and execute test automation frameworks for handheld devices and software solutions. Conduct testing before product launches, review requirements and budget. Analyze defect, des...
-
Senior Software Quality Assurance Engineers
Found in: Jooble US O C2 - 4 days ago
Woburn, MA, United States Randstad Digital Full timeSenior Software Quality Assurance Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop and execute test automation frameworks for handheld devices and software solutions. Conduct testing before product launches, review requirements and budget. Analyze defect, design, and technical documentation, and specifications, code,...
-
Senior Software Quality Assurance Engineers
5 days ago
Woburn, MA, United States Randstad Digital Full timeSenior Software Quality Assurance Engineers for Randstad Digital, LLC. Multiple openings. Headquarters: Woburn, MA. Develop and execute test automation frameworks for handheld devices and software solutions. Conduct testing before product launches, review requirements and budget. Analyze defect, design, and technical documentation, and specifications, code,...
-
Quality Engineer
Found in: beBee S US - 2 weeks ago
Woburn, United States Motion Recruitment Full timeOur client is a leading innovator in the medical device industry, dedicated to improving healthcare outcomes through cutting-edge technologies. They are seeking a highly skilled and motivated Quality Engineer specializing in Design Assurance to join their dynamic team. As a Quality Engineer, you will play a critical role in ensuring the quality and...
-
Design Assurance Engineer- Medical Device
2 weeks ago
Woburn, United States CEI Group Full timeDesign Assurance Engineer Responsibilities: Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory requirements. Working with the verification and validation efforts to ensure that the product meets design specifications and user requirements. Working with...
-
Design Assurance Engineer- Medical Device
2 weeks ago
Woburn, United States CEI Group Full timeDesign Assurance Engineer Responsibilities: Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory requirements. Working with the verification and validation efforts to ensure that the product meets design specifications and user requirements. Working with...
-
Quality Manager
3 days ago
Woburn, United States Boyd Full time**Job Title**: Quality Manager **Company Overview**: Boyd Woburn is a leading aerospace components manufacturing company dedicated to delivering high-quality products that meet or exceed industry standards. With a commitment to precision engineering and innovation, we strive to be a trusted partner in the aerospace industry. As part of our continuous...
-
Quality Engineer
5 days ago
Woburn, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team . This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do . Reporting...
-
Quality Engineer
3 days ago
Woburn, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team . This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do ....
-
Quality Engineer
7 days ago
Woburn, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...
-
Quality Engineer
1 week ago
Woburn, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...
-
Quality Engineer
Found in: Appcast US C2 - 2 weeks ago
Woburn, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...
-
Quality Engineer
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Woburn, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...
-
Quality Engineer
1 week ago
Woburn, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...
-
Manager, Quality Engineering
Found in: beBee jobs US - 3 weeks ago
Woburn, Massachusetts, United States Johnson & Johnson Full timeAbiomed, a part of Johnson& Johnson MedTech, is currently recruiting for a Manager, Quality Engineering. This position is based in Woburn, MA At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less...
-
Quality Engineer
2 weeks ago
Woburn, United States EHR Services Full timeJob DescriptionJob DescriptionCovaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide....
-
Quality Engineer
4 days ago
Woburn, United States EHR Services Full timeJob DescriptionJob DescriptionCovaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide....