-
Quality Engineer
1 week ago
Velocity Solutions North Walpole, United StatesAbout the Company · As a system partner of the office furniture industry, we specialize in the development and production of functional fittings made of metal and plastic. As one of the leading companies in Europe, we strive to quickly and flexibly fulfill individual customer req ...
-
Principal Quality Engineer
17 hours ago
Evolved By Nature Needham Heights, United StatesEvolved By Nature team is seeking a Principal Quality Engineer, responsible for driving and supporting all aspects of the quality system, quality through new product introductions, and quality within manufacturing. This position reports into the Senior Director, Quality, and is b ...
-
Principal Quality Engineer
1 week ago
Evolved By Nature Needham Heights, United StatesEvolved By Nature team is seeking a Principal Quality Engineer, responsible for driving and supporting all aspects of the quality system, quality through new product introductions, and quality within manufacturing. This position reports into the Senior Director, Quality, and is b ...
-
Site Quality Engineering Manager
1 week ago
Lockheed Martin Corporation Andover, United States**JOB ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**: · Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Mass ...
-
Site Quality Engineering Manager
1 week ago
Lockheed Martin Andover, United States**Job ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**:Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Massach ...
-
Senior CORE Quality Engineer
17 hours ago
SharkNinja Needham Heights, United StatesOur purpose is to positively impact people's lives every day in every home around the world We work very hard to provide our consumers with high-quality, exciting 5-star products that make life easier. We thrive on passion and innovation and are looking for great people, with gre ...
-
Senior CORE Quality Engineer
1 week ago
SharkNinja Needham, United StatesOur purpose is to positively impact people's lives every day in every home around the world We work very hard to provide our consumers with high-quality, exciting 5-star products that make life easier. We thrive on passion and innovation and are looking for great people, with gre ...
-
Quality Engineer
2 days ago
Busek Natick, United StatesJob Description · Job DescriptionAs a Quality Engineer, you will lead all aspects of product quality, providing technical direction for incoming and in-process inspections, leading root cause investigations, preparing deviations, waivers, and corrective action reports, and drivin ...
-
Senior CORE Quality Engineer
1 week ago
SharkNinja Needham, United States Full time· Our purpose is to positively impact people's lives every day in every home around the world We work very hard to provide our consumers with high-quality, exciting 5-star products that make life easier. We thrive on passion and innovation and are looking for great people, with ...
-
Quality Engineer
5 hours ago
Busek Natick, United StatesAs a Quality Engineer, you will lead all aspects of product quality, providing technical direction for incoming and in-process inspections, leading root cause investigations, preparing deviations, waivers, and corrective action reports, and driving nonconformance and problem repo ...
-
Quality Engineer
2 weeks ago
Busek Natick, United StatesAs a Quality Engineer, you will lead all aspects of product quality, providing technical direction for incoming and in-process inspections, leading root cause investigations, preparing deviations, waivers, and corrective action reports, and driving nonconformance and problem repo ...
-
Senior Quality Engineer
1 week ago
Bright Horizons Newton Center, United States Full timeBright Horizons is a leading education and care company, trusted by families and employers around the world for high-quality child care and early education, back-up care, and workplace education. We partner with some of the world's best companies to provide services that help emp ...
-
Senior Quality Engineer
1 week ago
AliMed Dedham, United StatesOur Company · AliMed is a leading medical products manufacturer and distributor with a vast portfolio of high-quality offerings designed to improve patient outcomes and experiences spanning hospital to home. We remain committed to serving the needs of both patients and providers ...
-
Senior Quality Engineer
1 day ago
Allurion Natick, United StatesJob Description · Job DescriptionWhy Allurion?We are overjoyed to be recognized as one of Deloitte's top 500 fastest-growing technology companies in the US But wait, there's even more excitement in store Get ready for an incredible new journey as we proudly announce our official ...
-
Design Quality Engineer
15 hours ago
Allurion Natick, United StatesJob Description · Job DescriptionWhy Allurion?We are overjoyed to be recognized as one of Deloitte's top 500 fastest-growing technology companies in the US But wait, there's even more excitement in store Get ready for an incredible new journey as we proudly announce our official ...
-
Senior Quality Engineer
1 week ago
The MathWorks Inc Natick, United StatesWill be responsible for developing and executing sophisticated software tests to identify software problems and their causes; developing software to test the accessibility and reliability of MathWorks' MATLAB and Simulink user community applications; participating in software dev ...
-
Manufacturing Quality Engineer
5 days ago
Allurion Natick, United StatesWhy Allurion? · We are overjoyed to be recognized as one of Deloitte's top 500 fastest-growing technology companies in the US But wait, there's even more excitement in store Get ready for an incredible new journey as we proudly announce our official public listing ALUR. This mom ...
-
Senior Quality Engineer
1 week ago
The MathWorks Inc Natick, United StatesWill be responsible for developing and executing sophisticated software tests to identify software problems and their causes; developing software to test the accessibility and reliability of MathWorks' MATLAB and Simulink user community applications; participating in software dev ...
-
Design Quality Engineer
13 hours ago
Allurion Natick, United StatesWhy Allurion? · We are overjoyed to be recognized as one of Deloitte's top 500 fastest-growing technology companies in the US But wait, there's even more excitement in store Get ready for an incredible new journey as we proudly announce our official public listing ALUR. This mom ...
-
Senior Quality Engineer
13 hours ago
Allurion Natick, United StatesWhy Allurion? · We are overjoyed to be recognized as one of Deloitte's top 500 fastest-growing technology companies in the US But wait, there's even more excitement in store Get ready for an incredible new journey as we proudly announce our official public listing ALUR. This mom ...
Principal Quality Engineer - Needham, United States - Evolved By Nature
Description
Evolved By Nature team is seeking a Principal Quality Engineer, responsible for driving and supporting all aspects of the quality system, quality through new product introductions, and quality within manufacturing. This position reports into the Senior Director, Quality, and is based in Needham, MA.
Responsibilities:
• Actively participate in the product development stage gate process. Lead risk analysis activities and FMEAs, and support verification and validation activities. Ensure quality is built into processes as transferred to manufacturing.
• Participates in design reviews, design transfers, and in all aspects of the Design Control process for the new product. Actively participate in and guide all aspects of Design Control and Change Control.
• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements.
• Ensure that all work activity is performed in accordance with established internal procedures, and FDA's Quality System Requirements.
• Responsible for timely review and approval of batch records, DHRs and batch release.
• Lead MRB team to ensure timely disposition of planned deviations and nonconforming material.
• Manage and support team with CAPAs and complaint investigations.
• Manage Deviations through their life cycle and review trends for corrective actions.
• Mentor and provide guidance to peers and quality team members on best practices.
• Support activities associated with agents of regulatory bodies as necessary to demonstrate quality system compliance.
• Support certification / recertification activities for US, European and other markets.
• Serve as an Internal Auditor to support the quality internal audit program.
• Develop and establish effective quality plans.
Requirements:
• Bachelors Degree and 10+ years of related Quality Engineering experience with combination or single use devices (or Master's Degree and 8+years of experience)
• Bachelor's degree in Chemical Engineering, Industrial Engineering, Process Engineering, Biomedical Engineering, or a Science field.
• Proven proficiency with quality tools and techniques in a manufacturing environment.
Skills & Abilities:
• Strong attention to detail.
• Strong written and verbal communication skills.
• Strong problem-solving skills & techniques.
• Well versed with ISO 13485 and FDA QSR standard.
• Experience as an internal or lead auditor a plus.
• Prior experience with MasterControl a plus.
Travel Requirements:
• Up to 10%
Evolved By Nature is a chemical technology company creating new molecules for a more sustainable future. We believe that the next generation of products will advance the health of people and the planet. We have developed molecules from our Activated Silk(tm) technology to create natural, higher performing ingredients that raise the quality and reduce the footprint of the products we need and love. Science meets commerce at our new home, a cutting-edge facility featuring state-of-the-art chemical laboratories, a contemporary wellness center, and creative marketing studio. To learn more about who we are, what we make, and where we work, visit