CAREER PORTAL

Associate Staff Quality Engineer – Software Development

Sr. Software Quality Engineer – Design Control & Compliance needed for a contract opportunity with Yoh Scientific’s client located in San Jose, CA.
 
This position will be for a major in vitro diagnostics company and requires someone with demonstrated competence in software development processes, good practices, and demonstrates ability to appropriately select and apply quality engineering tools and techniques.
 
Shift: Hybrid setting, 3x a week in the office.
 
Key Responsibilities

• 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 about 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 with 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 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.

 
Qualifications

• 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.).
• One or more of the following certifications is preferred for this role: 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!
Contract: 9-month contract with possibility of extension and/or conversion.
Salary:$52.15 - $74.50 hour depending on experience, W2.
Recruiter: Ery Baniqued
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

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!


Estimated Min Rate: $52.15
Estimated Max Rate: $74.50


What’s In It for You?
We welcome you to be a part of the largest and legendary 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. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

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.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.