- Abbott (Burlington, MA)
- …their lives. We are seeking an experienced Staff Engineer , Software Design Quality to ensure our medical devices are developed in accordance with Abbott's ... requirements and state of the art standards. The Staff Engineer , Software Design Quality will serve as...ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP Experience with… more
- Syner-G BioPharma Group (Boston, MA)
- …Experience: 4-7 years of experience within the biotech, pharmaceutical, or medical device industry.Knowledge and experience working with FDA cGMP, ... and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and… more
- Hologic (Marlborough, MA)
- …understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. Expertise in compliance issues and regulatory expectations. ... Principal Quality Assurance Engineer Marlborough, MA, United...Experience: Minimum 12+ years in the medical device industry. Proven track record in quality … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …true to the best of my knowledge. Job Description Title: Senior/Principal Engineer , Combination Products and Drug Delivery Devices Location: Cambridge, MA About the ... role: As a Senior/Principal Engineer , Combination Products and Drug Delivery Devices, you will provide project and technical leadership in the development,… more
- Integra LifeSciences (Mansfield, MA)
- …industry with knowledge of Risk Management (ISO 14971 2019), MDD ( Medical Device Directive), IEC 62366, ISO 13485 ( Quality Management Systems), FDA QSR and ... standards of care. This Staff Design & Reliability Assurance Quality Engineer is a key functional role...of DFSS techniques 8 years of experience in a Quality Assurance role for medical device… more
- Teleflex (Chelmsford, MA)
- …investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ... Quality Engineer 2, Product Quality... Quality Engineer 2, Product Quality Assurance Date:...in Engineering (or related technical field) 2-5 years related ( medical device preferred) experience Experience with statistical… more
- J&J Family of Companies (Raynham, MA)
- …applications will be considered. We are searching for the best talent for a Senior Quality Engineer located in Raynham, MA . The candidate will provide overall ... to applicable Global Regulations and standards (eg QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal… more
- Hologic (Marlborough, MA)
- …quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In ... Senior Product Quality Engineer Marlborough, MA, United States...Design Control requirements. In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk… more
- Hologic (Marlborough, MA)
- …a Senior Post Market Quality Engineer , you will lead quality engineering efforts for on-market medical devices. This role is responsible for evaluating ... Senior Post Market Quality Engineer Newark, DE, United States... System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management,… more
- Integra LifeSciences (Braintree, MA)
- …(Biomedical or Mechanical) or related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, ... treatment pathways to advance patient outcomes and set new standards of care. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for… more
