Sr. Quality Engineer
4 weeks ago
- Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required.
- Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness.
- Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally.
- Development of Master Validation Plan, Quality Plans and Reports
- Provide quality inputs and/or requirements as applicable.
- Focuses and determines proper engineering principles on reliability issues.
- Drive and own quality assurance and requirements during development phases and post-market release, including Change Control
- Implement lessons learned in other/new products, respectively new or running projects.
- Identify and manage Critical to Quality (CTQ's)
- dhere to defined and communicated Corporate Quality requirements, applicable Regulatory Standards, methods, and procedures, with openness to identifying improvements.
- Focus on streamlining activities for increased efficiencies.
- Control of Documentations
- Bachelor's degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
- Demonstrated competency with desired 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment.
- Proficiency in reading and interpreting mechanical drawings and GD&T.
- Medical Device Auditor certification preferred.
- Certified Six Sigma Black Belt, Green Belt or Lean Master preferred with proven completion of projects in which solutions were sought at the root level of the problem.
- Supplier Development and Management experience.
- Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO 13485, ISO 14971, and all other international regulatory requirements with which Client's complies.
- Design Control and/or Design Assurance experience
- Excellent analytical skills.
- Experience working in cross-functional, cross-business and cross-cultural projects.
- Hands-on personality.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
- 10% Travel
-
Sr. Quality Engineer
4 weeks ago
Pleasanton, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required. Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness. Support and/or drive Equipment and Process Validation,...
-
Sr. Product/Systems Engineer
7 days ago
Pleasanton, United States N6.com Full timeWe are a rapidly growing biotech startup based in Pleasanton CA with the mission to develop next-generation sample preparation tools for genomic applications. We are at an inflection point in bringing this technology to market and we are seeking to expand our engineering team with a Sr. Product/Systems Engineer. If you enjoy intellectually challenging...
-
Sr. Data Engineer
5 hours ago
Pleasanton, United States Talent Connection Full timeJob DescriptionJob DescriptionCompany DescriptionJoin Our Client's Team as a Sr. Data Engineer!At Talent Connection, we excel at matching exceptional talent with leading employers. We are currently seeking a Sr. Data Engineer to join our prestigious client’s team and help drive their innovative data solutions.About Our Client: Our client is a leading...
-
Sr Manager, Quality
1 week ago
Pleasanton, United States Omron Automation Full timeWork at OMRON! OMRON is a global leader in the field of automation , an $8 billion global technology company celebrating more than 90 years of success. OMRON's business fields cover a broad spectrum, ranging from industrial automation and electronic components to social systems and healthcare. OMRON Management Center of America, Inc. is the regional...
-
Sr. Mechanical Engineer
7 days ago
Pleasanton, United States N6.com Full timeWe are a rapidly growing biotech startup based in Pleasanton CA with the mission to develop next-generation sample preparation tools for genomic applications. We are at an inflection point in bringing this technology to market and we are seeking to expand our engineering team with a Sr. Mechanical Engineer. If you enjoy intellectually challenging projects in...
-
Sr. Electrical Engineer
1 month ago
Pleasanton, United States N6.com Full timeWe are a rapidly growing biotech startup based in Pleasanton CA with the mission to develop next-generation sample preparation tools for genomic applications. We are at an inflection point in bringing this technology to market and we are seeking to expand our engineering team with a Sr. Electrical Engineer. If you enjoy intellectually challenging projects in...
-
Sr. SRE Lead Engineer
1 month ago
Pleasanton, United States CareerBuilder Full timeJob Title: Sr. SRE Lead Engineer Location: Pleasanton, CA//Onsite Duration: Full Time-Only JOB DESCRIPTION: Troubleshoot production issues and restore service by resolving customer-facing incidents Troubleshoot and implement corrections to problems associated with connectivity between the supported applications and the clients they serve Provide technical...
-
Sr. SRE Lead Engineer
1 month ago
Pleasanton, United States Diverse Lynx Full timeJob Title: Sr. SRE Lead Engineer Location: Pleasanton, CA//Onsite Duration: Full Time-OnlyJOB DESCRIPTION: Troubleshoot production issues and restore service by resolving customer-facing incidents Troubleshoot and implement corrections to problems associated with connectivity between the supported applications and the clients they serve Provide technical...
-
Sr Principal, Software Development Engineer
7 days ago
Pleasanton, United States Workday Full timeYour work days are brighter here. At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us apart was our culture. A culture which was driven by our value of putting our...
-
Quality Engineer
7 days ago
Pleasanton, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Should be able to handle stress and pressure at times 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment. Team player Design Control and/or Design Assurance experience Risk management Supplier Development and Management...
-
Quality Engineer
4 days ago
Pleasanton, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required. Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness. Support and/or drive Equipment and Process Validation,...
-
Quality Engineer
4 weeks ago
Pleasanton, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Should be able to handle stress and pressure at times 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment. Team player Design Control and/or Design Assurance experience Risk management Supplier Development and...
-
Engineer II, Quality
1 week ago
Pleasanton, United States Abbott Laboratories Full timeJob TitleEngineer II, QualityWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment...
-
Sr. UI Engineer
1 week ago
Pleasanton, United States Diverse Lynx Full time: Sr. UI Engineer (ADA - Accessibility) Job Summary: Strong Front end skills of over 9 years. Skill + Experience in leading 3-4 developers and mentoring the team. Experience in working with Solution Architect for Design and providing recommendations. Perform Design and Code reviews. Roles & Responsibilities: •Responsible for developing and designing front...
-
Mechanical Project Engineer
7 days ago
Pleasanton, United States WB Engineers+Consultants Full timeWorks independently to complete the majority of projects from start to finish with limited assistance from a Senior Engineer or Director. Job Summary Lead the client management and design production activities Coordinate and ensure the thoroughness and accuracy ofbuilding systems surveys Support the development of designs, specifications, systems narratives,...
-
Senior Associate Quality Assurance Analyst
1 week ago
Pleasanton, United States Workday Full timeYour work days are brighter here. At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us apart was our culture. A culture which was driven by our value of putting our...
-
Senior Software Quality Engineer
2 weeks ago
Pleasanton, United States Abbott Laboratories Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Job...
-
Mechanical Project Engineer
1 month ago
Pleasanton, United States WB Engineers+Consultants Full timeWorks independently to complete the majority of projects from start to finish with limited assistance from a Senior Engineer or Director. Job SummaryLead client management and design production activities for building infrastructure projectsCoordinate and ensure the thoroughness and accuracy of building systems surveysSupport the development of designs,...
-
Mechanical Project Engineer
1 month ago
Pleasanton, United States WB Engineers+Consultants Full timeWorks independently to complete the majority of projects from start to finish with limited assistance from a Senior Engineer or Director. Job SummaryLead client management and design production activities for building infrastructure projectsCoordinate and ensure the thoroughness and accuracy of building systems surveysSupport the development of designs,...
-
Mechanical Project Engineer
1 month ago
Pleasanton, United States WB Engineers+Consultants Full timeJob DescriptionJob DescriptionWorks independently to complete the majority of projects from start to finish with limited assistance from a Senior Engineer or Director. Job SummaryLead the client management and design production activitiesCoordinate and ensure the thoroughness and accuracy of building systems surveysSupport the development of designs,...