Staff Design Quality Engineer

job summary: The Senior Staff Quality Software Engineer is a recognized technical expert responsible for leading complex quality engineering initiatives across multiple projects or product lines. This role applies advanced knowledge and expertise in quality architecture to

ensure delivery of reliable, scalable, and high-performing software solutions. Operating with significant independence, the engineer mentors others, drives innovation in QA practices, and influences organizational quality standards.

location: Menlo Park, California job type: Contract salary: $70 - 80 per hour work hours: 9 to 5 education: Bachelors

responsibilities:

• Drive continuous improvement initiatives, evaluating and adopting emerging QA tools, techniques, and methodologies.
• Lead cross-functional defect prevention and root-cause analysis efforts, ensuring systemic issues are identified and addressed.
• Partner with engineering, DevOps, and product teams to integrate quality best practices into development and deployment pipelines.
• Serve as a mentor and technical advisor to QA engineers, developers, and technicians, fostering skill development and knowledge sharing.
• Define and monitor quality KPIs, providing strategic insights and recommendations to senior leadership.
• Represent quality engineering in architecture reviews, release planning, and technical decision-making.
• Advocate for and drive adoption of a "quality-first" mindset across engineering teams

qualifications:

• Bachelor's degree in Computer Science, Software Engineering, Information Systems, or related field. 12+ years of relevant experience in software quality assurance, testing, or software development, OR
• Master's degree with 10+ years of relevant experience, OR PhD with 8+ years of relevant experience.
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
• GMP quality management systems (e.g. ISO 13485)
• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
• Cybersecurity principles, tools, and control frameworks (e.g. ISO 27001, NIST, SOC 2, HIPAA)
• Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
• Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Essential Skills

• Expert-level knowledge of software QA methodologies, SDLC, and modern quality engineering practices.
• Exceptional analytical, debugging, and problem-solving skills for highly complex technical challenges.
• Proven experience leading quality engineering initiatives and influencing technical direction across teams.
• Strong leadership and mentoring abilities with a track record of developing high-performing QA professionals.
• Excellent communication and interpersonal skills, with the ability to influence at multiple levels of the organization.

skills: Medical Device Product Development

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

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.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

,

• Drive continuous improvement initiatives, evaluating and adopting emerging QA tools, techniques, and methodologies.
• Lead cross-functional defect prevention and root-cause analysis efforts, ensuring systemic issues are identified and addressed.
• Partner with engineering, DevOps, and product teams to integrate quality best practices into development and deployment pipelines.
• Serve as a mentor and technical advisor to QA engineers, developers, and technicians, fostering skill development and knowledge sharing.
• Define and monitor quality KPIs, providing strategic insights and recommendations to senior leadership.
• Represent quality engineering in architecture reviews, release planning, and technical decision-making.
• Advocate for and drive adoption of a "quality-first" mindset across engineering teams

Medical Device Product Development