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Design Assurance Director
1 week ago
Boston Scientific Corporation Waltham, United States**Work mode**:Hybrid**Onsite Location(s)**:Waltham, MA, US, 02138**Additional Location(s)**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** · - At Boston Scientific, we'll give you the opportunity to harness all that's within you ...
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Design Assurance Engineer
2 weeks ago
Motion Recruitment Partners, LLC Woburn, United StatesOur 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 se ...
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Design Assurance Engineer
3 weeks ago
Motion Recruitment Partners LLC Woburn, United StatesOur 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. · Theyare see ...
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Quality Engineer, Design Assurance
2 weeks ago
TalentBurst Woburn, United States ContractTitle: Quality Engineer, Design Assurance · Location: Woburn, MA · Duration: 12+ Months · Job 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 Qua ...
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Design Assurance Engineer- Medical Device
3 weeks ago
CEI Group Woburn, United StatesDesign 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 ensur ...
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Design Assurance Engineer-Medical Devices
2 weeks ago
CEI Group Woburn, United StatesDesign 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 ...
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Design Assurance Engineer- Medical Device
1 week ago
CEI Group Woburn, MA, United StatesDesign Assurance Engineer Responsibilities: Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory ; · Working with the verification and valida · ...
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Design Assurance Director
1 week ago
Boston Scientific Watertown, United StatesThe Design Assurance Director is a unique opportunity for a strong leader to work on a high-performing, cross-functional product development team to design and maintain world-class Electrophysiology Systems. The Design Assurance Director will serve a Director, Assurance, Design, ...
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Design Assurance Director
1 week ago
Boston Scientific Waltham, United StatesAdditional Location(s): N/A · Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance · At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling ...
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Design Assurance Director
1 week ago
Boston Scientific Waltham, United StatesAbout the role: · The Design Assurance Director is a unique opportunity for a strong leader to work on a high-performing, cross-functional product development team to design and maintain world-class Electrophysiology Systems. The Design Assurance Director will serve as the Site ...
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Plant Manager
2 weeks ago
BD Woburn, United States**Job Description Summary**: The Plant Manager is responsible for materials management, planning and for staffing and managing plant activities and people to optimize operational efficiencies to provide a competitive cost and value advantage for Surgery products. Exceed customers ...
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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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Material Handler 1
3 weeks ago
Electric Supply Center Woburn, United States**Company Summary**: Electric Supply Center is one of the largest independent distributors of electrical components in New England. Our clients range from local electrical contractors to multi-national construction companies. Starting in 1971, our business has grown to 6 location ...
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Quality Coordinator
3 weeks ago
Parker Hannifin Corporation Woburn, United States**Position Summary** · Parker Chomerics, a Fortune 250 company, is solving the world's greatest engineering challenges and driving the future of electronics technology. Parker Chomerics is a world leader in the development and manufacture of high-quality products that enable engi ...
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Tax & Audit Associate
3 weeks ago
BA, Inc. Woburn, United States**Hybrid Options, Work/Life Balance**: · BA, Inc. is a regional accounting and advisory services firm focused on helping small and medium size businesses achieve their financial goals. Since 2003, Architects, Designers, Real Estate Developers & Operators, and Professional Service ...
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BCM Controls Corporation Woburn, United States**Who we are**: · At BCM Controls, we are focused on our people, our culture, and our business. Our goal is to be the "Best Place You Will Ever Work" We are growing and looking to hire great people to support our vision. BCM specializes in building automation, security systems an ...
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Director of Maintenance
2 weeks ago
Shepherd's Run Wakefield, United StatesJob Title: Director of Maintenance · Supervisor: General Manager · FLSA Status: Exempt, Full Time · Summary · **Qualifications**: · To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are repres ...
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Design Assurance Quality Engineer III
3 weeks ago
Omnicell Cranberry, United StatesJob Description · Quality Assurance Engineer III, Design Assurance · Reporting to the Director or Manager of Quality Design Assurance, the Quality Design Assurance Engineer will be responsible for leading Design Assurance activities in collaboration with cross-functional person ...
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Sr. Design Quality Assurance Engineer
1 week ago
Boston Scientific Marlborough, United StatesAdditional Location(s): N/A · Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance · At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tacklin ...
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Design Quality Assurance Engineer II
3 weeks ago
Boston Scientific Marlborough, United StatesAdditional Location(s): N/A · Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance · At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tacklin ...
Quality Engineer, Design Assurance - Woburn, United States - TalentBurst
Description
Title:
Quality Engineer, Design AssuranceLocation: Woburn, MADuration: 12+ Months
Job 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 Design History Files and IVDR Class A Technical Documentation for existing Covaris systems.
The ideal candidate will be a self-motivated professional with a strong background in engineering and a commitment to excellence .
This position will require candidate to be on site at least 3 days a week. The contractor operates in support of ISO 13485 certification and IVDR remediation.Responsibilities include:
Actively support product development initiatives with Design Assurance services including authoring documentation. Support Product Development with quality documentation as needed. Escalate potential issues that could impact compliance. Establish technical documentation in support of IVDR Class A systems. Establish System Level Design History Files Identify and fill gaps in historical records. Perform design verification and validation activities as needed. Establish system level risk management files. 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.
Conduct investigations of identified problems with existing products in the field and production. Use Complaints, NCMR, CAPA, and DCO processes to modify product design or manufacturing procedures as required. Administer and improve quality processes, with a focus on Lean process management. Assist manufacturing and product development with documentation, guidance, and execution of design verification/validation and process validation.Non-
Essential Responsibilities:
The employee may be required to perform other non-essential functions, follow any other job-related instructions, and 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. Continually strives to improve. A minimum of 5+ years of working experience in Design Assurance or Systems Engineering. Excellent technical writing skills Understand design controls, change controls, phase gated product development processes.
Demonstrated track record with 21 CFR 820.30, ISO 13485, the IVDR (Class A) and ISO Demonstrated track record implementing risk management files.
Able to create multi-source reports, trends, and interpret data with minimal oversight. Communicates effectively both verbally and in writing Acts decisively with Integrity and Kindness.Note:
The candidate must be a contractor and possess flexibility in their schedule to accommodate the standardized 40-hour workweek at the Woburn, MA corporate office.
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Quality Engineer, Design Assurance professionals in Woburn
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Jay Crispo
Enterprise Workload Automation Administrator