Associate Staff Quality Engineer – Software Development
Associate Staff Quality Engineer - Software Development / San Jose ONSITE
9 month contract - strong possibility to go direct hire
W2 Pay rate:
$62.00 - $74.00/hr
Software support
Risk management ISO14971
CSQE - desired
Summary
Ensures compliance to global and local Product Development Process procedures, through proper development and testing of product software. Ensures compliant transfer of product software to manufacturing according to established procedures to meet all quality requirements. Provides guidance to R&D teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.
Duties
Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
Opportunity is Calling, Apply Now!
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
Note:
Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https:
//www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.Estimated Salary: $20 to $28 per hour based on qualifications.
9 month contract - strong possibility to go direct hire
W2 Pay rate:
$62.00 - $74.00/hr
Software support
Risk management ISO14971
CSQE - desired
Summary
Ensures compliance to global and local Product Development Process procedures, through proper development and testing of product software. Ensures compliant transfer of product software to manufacturing according to established procedures to meet all quality requirements. Provides guidance to R&D teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.
Duties
- Quality Engineering Support for product software Design Control Process Implement/facilitate product risk management planning as needed. Facilitate and participate in product software design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary.
- Leads risk management for R&D, including updating risk files based on customer complaint feedback, assessing risk of proposed changes, and performing risk analysis for R&D projects.
- Serve as primary contact for assigned R&D projects and provide coaching / mentoring to project managers and/or product software development team in regard to the product development process, design control, risk assessment, etc.
- Review and provide feedback on design documentation to support the product development process.
- Participate in technical or specialty design review(s) for product development and participate as QA representative in the design change management process for product development.
- Assists in the development, review, and execution of quality management system areas (e.g. change control, document control, risk analysis, design control, verification and validation, etc.).
- Develop and/or edit standard operating procedures.
- Contribute to maintain compliance to quality systems and programs in the areas of change management, design control, product verification and validation, initiating CAPAs for relevant design issues, etc, to ensure compliance with FDA and regulatory requirements.
- Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits.
- Participates in CAPA activities, including investigation, effectiveness, and root cause analysis. Supports implementation of corrective actions and preventive measures.
- Bachelor's degree in science related field e.g. computer science, engineering, biology, etc
- Requires a minimum of eight (8) years experience in a related industry regulated by FDA.
- Requires demonstrated competence in software development processes, good practices, and demonstrates ability to appropriately select and apply quality engineering tools and techniques.
- Experience applying risk management using ISO 14971
- Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
- Requires effective written and oral communication skills to interact across all levels of the organization.
- Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
Opportunity is Calling, Apply Now!
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
Note:
Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https:
//www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.Estimated Salary: $20 to $28 per hour based on qualifications.
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