Principal Quality Engineer
1 month ago
MAJOR DUTIES AND RESPONSIBILITIES
Responsibilities include:
- Support new product development projects to include the following: (1) Design control, risk management, biocompatibility, verification/validation testing, sterilization, packaging, and change control.
- Provide Quality Engineering leadership and support for commercial medical device production: (1) Test method assessment and improvement (Test Method Validation, GR&R). Perform data analysis, trending, change control, and deviation support activities. (2) NCR, Complaints and CAPA investigation and review, including: risk analysis, impact assessment, root cause analysis tools, and material dispositions.
- Receiving and Incoming Inspection Process Management: (1) Materials handling and transfer management and improvements. This will include development, clinical, and commercial phase-appropriate controls. (2) Component specification implementation, revision, and management. (3) Provide technical support for routine incoming inspection
- Equipment management and validation activities. Establish IQ/OQ, preventive maintenance and calibration requirements.Review software risk assessments, validation protocols and reports.
- Clean room and CDA (re-)qualification and periodic monitoring processes (particulate, airflow, and viables). Environmental monitoring system management (Rees), updates and validation.
- Support activities related to sterilization management (ETO and E-beam).
- Support other quality system processes as needed, and audits by regulatory agencies and third parties.
QUALIFICATIONS
Experience
- Minimum 10 years medical device (Class III preferred) experience with progressive responsibilities.
- Experience in quality systems under applicable cGMP/Quality Systems Regulations (ISO 13485, 21 CFR 820, and MDD/MDR).
- Demonstrated excellent written and oral communication skills with a track record of strong organizational and interpersonal skills. Must be able to define problems, collect data, establish facts, and draw valid conclusions.
- Computer skills: Microsoft Office (Word, Excel, PowerPoint), and statistical software such as Minitab or JMP.
- Must be familiar with sampling plans such as ANSI Z1.4, Z1.9, and zero acceptance number sampling.
- Must be familiar with root cause analysis tools (6Ms, 5 whys, fishbone/Ishikawa diagrams, etc.)
EDUCATION REQUIREMENTS
- Bachelor’s degree in Engineering or related field
-
Principal Quality Engineer
1 month ago
milpitas, United States Elixir Medical Corporation Full timeMAJOR DUTIES AND RESPONSIBILITIESResponsibilities include:Support new product development projects to include the following: (1) Design control, risk management, biocompatibility, verification/validation testing, sterilization, packaging, and change control.Provide Quality Engineering leadership and support for commercial medical device production: (1) Test...
-
Principal Quality Engineer
1 month ago
Milpitas, United States Elixir Medical Corporation Full timeMAJOR DUTIES AND RESPONSIBILITIESResponsibilities include:Support new product development projects to include the following: (1) Design control, risk management, biocompatibility, verification/validation testing, sterilization, packaging, and change control.Provide Quality Engineering leadership and support for commercial medical device production: (1) Test...
-
Principal Manufacturing Engineer
4 weeks ago
Milpitas, California, United States MKS Instruments Full timeAbout the Role:We are seeking a highly skilled Principal Manufacturing Engineer to join our team at MKS Instruments. As a key member of our team, you will be responsible for developing and manufacturing cutting-edge laser technology products.Key Responsibilities:Collaborate with Product Development Engineering to develop and manufacture innovative laser...
-
Principal Manufacturing Engineer
1 month ago
Milpitas, California, United States MKS Instruments Full timeJob SummaryMKS Instruments is seeking a skilled Principal Manufacturing Engineer to join our team in the Lasers Business Unit. As a key member of our Product Development Engineering team, you will be responsible for developing and manufacturing cutting-edge laser technology products. If you have a passion for working in a team environment and are self-driven...
-
Milpitas, United States ZipRecruiter Full timeJob DescriptionCompany DescriptionAt Western Digital, we are on a mission to unlock the potential of data so people, companies and organizations everywhere can create what’s next. To fulfill our vision, we are always on the lookout for potential team members who share our passion for solving problems to empower others.When you join Western Digital, you...
-
Quality Engineer
2 months ago
Milpitas, United States ATR International Full timeJob DescriptionJob DescriptionThe Quality Engineer reports directly to the Quality Manager and is responsible for developing, implementing the internal manufacturing quality processes and procedures. This includes continuous improvement and review of assemblies and also customer support for quality initiatives. Essential Functions and...
-
Milpitas, United States Western Digital Full timeCompany DescriptionAt Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible.At our core, Western Digital is a company of problem solvers. People achieve extraordinary things given the right technology. For decades, we’ve been doing just that. Our technology...
-
Supplier Quality Engineer
3 weeks ago
Milpitas, United States Flex Full timeJob Posting Start Date 11-04-2024 Job Posting End Date 01-04-2025Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive...
-
Principal Consultant, QA Analyst
2 months ago
Milpitas, United States Genpact Full timeGenpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we...
-
Principal Consultant, QA Analyst
1 month ago
Milpitas, California, United States Genpact Full timeJob Title: Principal Consultant, QA AnalystGenpact is a global professional services and solutions firm delivering outcomes that shape the future. Our team is driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. We serve and transform leading enterprises, including the Fortune Global 500, with our deep...
-
Senior Supplier Quality Engineer
1 week ago
Milpitas, United States MKS Instruments Full timeA Day in Your Life at MKS:As Supplier Quality & Development Engineer at MKS‘ Global Supply Chain organization, you will partner with Global Supply Chain - Category Management, Procurement, Design Engineering, Manufacturing Engineering, Manufacturing/Operations, Quality, and others to execute supplier quality management and development activities within the...
-
Principal Consultant, QA Analyst
2 months ago
Milpitas, United States Genpact Full timeGenpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people –...
-
Senior Quality Assurance Engineer
4 weeks ago
Milpitas, California, United States Genpact Full timeAt Genpact, we are seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a Senior Quality Assurance Engineer, you will be responsible for developing a comprehensive framework for software testing and organizing testing activities for new and existing releases. You will also coordinate with other QA Leads, project managers,...
-
Supplier Quality Engineer
4 weeks ago
Milpitas, California, United States MKS Instruments Full timeAbout the Role:As a Supplier Quality Engineer at MKS Instruments, you will be part of our Global Supply Chain organization, working closely with various teams to execute supplier quality management and development activities. Your primary goal will be to partner with suppliers to grow their capabilities and drive robust processes.Key Responsibilities:Execute...
-
Manufacturing Engineer
4 weeks ago
Milpitas, California, United States KLA Full timeJob Summary:We are seeking a highly skilled Manufacturing Engineer to join our team at KLA. As a key member of our manufacturing engineering team, you will be responsible for providing technical support and expertise to our manufacturing teams, ensuring the successful build and quality of our stage system level challenges.Key Responsibilities:Provide...
-
Manufacturing Engineer
4 weeks ago
Milpitas, California, United States KLA Full timeJob Summary:KLA is seeking a highly skilled Manufacturing Engineer to join our team. As a Manufacturing Engineer, you will be responsible for providing manufacturing engineering support for stage system level challenges, leading issues on manufacturing tool builds, and ensuring problems are resolved.Key Responsibilities:Provide manufacturing engineering...
-
Milpitas, United States Western Digital Full timeCompany DescriptionAt Western Digital, we are on a mission to unlock the potential of data so people, companies and organizations everywhere can create what’s next. To fulfill our vision, we are always on the lookout for potential team members who share our passion for solving problems to empower others.When you join Western Digital, you join a legacy more...
-
Customer Service/Quality Engineer
3 weeks ago
Milpitas, United States SIX SIGMAWinslow Automation Inc. Full timeCompany Description:Six Sigma (the services division of Winslow Automation, Inc.) is the industry expert in the soldering and modification of high-reliability integrated circuits for space, telecommunications, military, and medical industries. With 35+ years of experience, we are one of the few remaining semiconductor manufacturing companies in Silicon...
-
Quality Technician
2 weeks ago
Milpitas, United States Aerotek Full timeJob DescriptionJob DescriptionJob Title: Quality Technician Job DescriptionQuality Tech 5:Audits processes, tests, and inspects products and/or develops, compiles, and evaluates statistical data to determine and maintain quality and reliability of products. Working from engineering drawings, specifications, schematics, diagrams, written descriptions,...
-
Milpitas, United States ZipRecruiter Full timeJob DescriptionCompany DescriptionAt Western Digital, we are on a mission to unlock the potential of data so people, companies, and organizations everywhere can create what’s next. To fulfill our vision, we are always on the lookout for potential team members who share our passion for solving problems to empower others.When you join Western Digital, you...