- Work with Product Development, Operations, and other departments to ensure regulatory compliance to POGO meter and cartridge manufacturing in accordance with 21CFR820 and ISO
- Develop and execute Quality Engineering activities to meet commercial milestones.
- Support the analysis and evaluation of production capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective.
- Develop and implement product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical-to-quality attributes.
- Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process.
- Participate in Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485, 21CFR 820 and IVDD.
- Train and mentor team members on best practices in quality engineering and regulatory compliance.
- Work with Product Development, Operations, and other departments to ensure regulatory compliance to manufacturing in accordance with 21CFR820 and ISO
- Develop and execute Quality Engineering activities to meet commercial milestones.
- Support the analysis and evaluation of production capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective.
- Develop and implement product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical-to-quality attributes.
- Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process.
- Participate in Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485, 21CFR 820 and IVDD.
- Train and mentor team members on best practices in quality engineering and regulatory compliance.
- Train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMEA, DOE, and statistical methods.
- Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures, or tools as necessary.
- Assist in the development, improvement, and management of product assurance systems such as incoming quality inspection, in-process quality assurance, statistical process control, calibration / preventative maintenance, CAPA, nonconforming materials, product lot release testing, and finished goods control.
- Participate in internal and external audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.
- Strong reading, writing, and speaking competency in English
- Fluent in a wide variety of Quality tools such as Fishbone, 8D, 6S, 5 Why Analysis processes.
- Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software such as Minitab or JMP.
- Working knowledge of regulatory requirements such as QSR, ISO13485, and IVDD
- Strong collaboration, team building and development skills
- Strong written, verbal, and interpersonal skills
- Prior experience working in emerging, start-up companies desired
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Info Way Solutions Fremont, United StatesHi · Hope you are doing well · My name is Dinesh ; I am a Technical Recruiter with Info Way Solutions LLC. · I have a requirement of below position, share me the resume of your consultants accordingly. · Please Find Required Details as well JD Below · Job Role - Quality Engi ...
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Info Way Solutions Fremont, United StatesHiHope you are doing wellMy name is Dinesh ; I am a Technical Recruiter with Info Way Solutions LLC.I have a requirement of below position, share me the resume of your consultants accordingly.Please Find Required Details as well JD BelowJob Role - Quality Engineer III (US) - Mobi ...
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Senior Quality Engineer - Fremont, United States - Online Technical Services
Description
Job DescriptionJob DescriptionSenior Quality Engineer - Medical
Company Overview:
We are a privately held, fast-paced medical device company located in Fremont, CA that is developing a greatly simplified glucose monitoring system for people with diabetes.
Position Summary:
The Senior Quality Engineer is responsible for providing quality engineering support for manufacturing on a day-to-day basis to ensure regulatory compliance.
Duties and Responsibilities:
7+ years of experience in a quality engineering role in the medical device industry with experience in complex systems strongly preferred.
