Quality Engineer I - Instrumentation Quality Engineer

"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 13485 environment
• Experience with design controls, change control, and product impact assessments
• Working knowledge of applicable medical device quality system and regulatory requirements, including ISO 13485, 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 14971
• 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 60601 series and ISO 14971
• 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.