- Abbott (Temecula, CA)
- …or Technical Field or equivalent experience + At least 7 years Software Quality Engineering experience. + Detailed knowledge of FDA , GMP, IEEE 1012 and ISO ... heartbeats. Our location in **Temecula, CA,** currently has an opportunity for a **Senior Software Quality Engineer** . **THIS POSITION CAN ALSO BE BASED OUT OF… more
- Abbott (Kansas City, MO)
- …working mothers, female executives, and scientists. **The Opportunity** The **Lead Software Quality Engineer** position within the Toxicology Business Unit, ... closely with cross-functional teams to develop, implement, and maintain software quality processes and standards, while also...of FDA 21 CFR part 820 (US FDA Quality Systems Regulation), 21 CFR part… more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... understanding of medical device software standards such as IEC 62304. ** Software Quality Engineering Expertise:** 1. Hands-on experience in Software … more
- Medtronic (Los Angeles, CA)
- …compassionate world. **A Day in the Life** Careers That Change Lives The Senior Software Quality Engineer works as part of the core new product development ... Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as… more
- Medtronic (Los Angeles, CA)
- …Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ... . + Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements… more
- Medtronic (Los Angeles, CA)
- …Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ... . + Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements… more
- Abbott (Alameda, CA)
- …160 countries. **Position Location: Alameda, CA** **The Opportunity** This **Manager, Software Quality Assurance** is responsible for providing assurance that ... Quality Engineers, Specialists, and/or other staff on the Software Quality Assurance Team. + Participate as...3+ years' experience leading a team of technical and/or quality professionals. + Knowledge of FDA QSR,… more
- Abbott (Pleasanton, CA)
- …health and get on with their lives. We are seeking an experienced **_Senior Software Quality Engineer_** to ensure our medical devices are developed in ... and state of the art product standards. The **_Senior Software Quality Engineer_** will serve as a...JIRA). + Experience with FMEA/risk management. + Knowledge of FDA regulations and software guidance, IEC 62304,… more
- Abbott (Burlington, MA)
- …health and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance ... Engineer_** will serve as a technical representative providing software quality expertise to product development teams....FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and… more
- Medtronic (Lafayette, CO)
- Position Description: Provide coordination to cross functional groups to ensure software quality objectives are met for product software , manufacturing ... Life Cycle) including complex government and industry regulations including FDA 21 CFR Parts 11 and 820, ISO 13485,...software packages to include Minitab. Define and implement software quality metrics to track software… more
- Actalent (Carlsbad, CA)
- Job Title: Software Quality Assurance Engineer Job Description Responsibilities: * Design, develop, and implement quality assurance standard operating ... approve test plans and test cases to ensure that software meets desired quality and performance standards....tools or packages are up to date. * Own software -related FDA 510(k) submission documents. * Participate… more
- Abbott (Lake Forest, IL)
- …mothers, female executives, and scientists. **The Opportunity** The **Sr. Manager - Global Software Quality ** works out of our **Lake Forest, IL** location in ... : Drive continuous improvement activities using project management skills, and lead software validation and quality assurance efforts. + **Develop Programs** :… more
- DEKA Research & Development (Manchester, NH)
- …+ Must be able to work onsite Monday-Friday + Nice to have: + Knowledge of FDA 's Quality System Regulation + Knowledge of ISO 13485 and related standards About ... Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative… more
- Abbott (Abbott Park, IL)
- …focused on validation and design control of products and processes, including software and technical quality assurance personnel. Products include PC application ... of regulatory changes. This role will provide oversight and management for the software (digital and embedded) and technical quality organization, ensuring that… more
- Teleflex (Chelmsford, MA)
- …or Physical Sciences preferred. * Two years of working experience with software quality assurance required. * Clear understanding and working experience ... and methodical problem-solving approach. * Understanding of design controls, software quality assurance, and risk management. *...FDA QSR's. * Advanced skills in MS Office, software defect tracking tools preferred. * Understanding of IEC… more
- Abbott (Westford, MA)
- …and scientists. Our location in **Westford, MA** currently has an opportunity for a ** Software Quality Design Engineer** **.** **THIS IS AN ON-SITE DAILY ROLE.** ... change management + Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and… more
- Medtronic (Lafayette, CO)
- …world. **A Day in the Life** We are currently looking for a **Senior Software Quality Engineer** to join our Cranial and Spinal Technologies operating unit ... Lafayette, Colorado. In this exciting role as a **Senior Software Quality Engineer** **,** you will represent...policies and Standard Operating Procedures (SOPs) to ensure that FDA , ISO and European Medical Device quality … more
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) **Senior Design Quality Engineer - ... Software (Hybrid)** **Stryker** is hiring a **Senior Design Quality Engineer - Software ** as part of...and Cybersecurity Risk Assessments by working with current product quality data, FDA MAUDE database, and other… more
- System One (Lakewood, CO)
- Title: Lead Design Quality Engineer - Embedded Software & Medical Devices Location: Lakewood, CO - on-site 3 days/week Type: Direct Hire Shift/Schedule: M-F 8am ... - $154,500.00 with 10% bonus Our client is looking for a Lead Design Quality Engineer with proven skills in embedded software coding, design control, and… more