Quality Engineer I - Instrumentation Quality Engineer, Lake Forest

Job Description Job Description "All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Title: Quality Engineer I - Instrumentation Quality Engineer
Location: Lake Forest, CA - onsite
Contract Length: 6 months with potential to be extended
Pay Range: $35/hr.
- $45/hr.
on W2
Job Description:
In this role, you will work closely with R&D, Regulatory, Operations, and other cross-functional stakeholders to provide hands-on quality engineering support across the product development lifecycle.
You will contribute to key activities such as design controls, risk management, verification and validation, supplier-related quality support, change control, and product transfer.
The ideal candidate brings strong technical judgment, demonstrated quality capability, and the ability to operate independently in a fast-paced environment.
Major Accountabilities:
Provide hands-on quality engineering support for new product development projects and design changes to existing instrumentation products
Ensure quality requirements are appropriately applied throughout development, documentation, verification, validation, and transfer activities
Partner with project teams to provide practical quality guidance, technical assessment, and risk-based decision support that helps keep development activities moving forward
Review and approve design control deliverables, including risk management files, verification and validation documentation, and related development records
Evaluate product and process changes for quality and regulatory impact, and support change control activities from assessment through implementation
Partner with cross-functional teams to investigate deviations, support root cause analysis, and drive corrective and preventive actions as needed
Maintain compliance with applicable GxP requirements, standard operating procedures, and documentation practices
Minimum Qualifications
Bachelors degree in engineering, life sciences, or a related technical field
2+ years of quality engineering experience in the medical device industry, including direct support of instrumentation or electromechanical product development in an ISO ***** environment
Experience with design controls, change control, and product impact assessments
Working knowledge of applicable medical device quality system and regulatory requirements, including ISO *****, design controls and GxP principles
Ability to work effectively across global, cross-functional teams, communicate clearly with technical and non-technical stakeholders, and contribute with minimal ramp-up
Experience with risk management in accordance with ISO *****
Experience reviewing or supporting verification and validation protocols, reports, and related documentation
Preferred Qualifications
Statistical knowledge to support sample size determination and the design of verification and validation studies
Working knowledge of applicable product and safety standards, such as the IEC ***** series and ISO *****
ASQ Certified Quality Engineer (CQE) certification
Six Sigma Green Belt or higher
Strong communication, organization, collaboration, and independent problem-solving skills
About ASK : ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally.
With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all associates.