Quality Engineer III
Iconma
Santa Clara, CA
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JOB DETAILS
SKILLS
Biomedical Engineering, Change Control, Chemical Engineering, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Engineering, Engineering Change Order, FDA Requirements, Failure Mode and Effects Analysis (FMEA), Health Plan, Healthcare, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Problem Solving Skills, Product Lifecycle, Product Safety, Project/Program Management, Quality Engineering, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Research & Development (R&D), Risk Management, Root Cause Analysis, Technical Support, Technical Writing, Validation Plan, Validation Testing, Verification Plans, Writing Skills
LOCATION
Santa Clara, CA
POSTED
Today
Responsibilities:
- Lead and execute quality engineering activities throughout product lifecycle, including design controls, risk management, and verification & validation planning.
- Author, review, and maintain high quality technical documentation, including protocols, reports, and engineering specifications.
- Facilitate and drive cross functional engineering review meetings to ensure alignment on quality and regulatory expectations.
- Apply 21 CFR 820 Quality System Regulation requirements to ensure compliance across design and manufacturing processes.
- Develop, maintain, and execute DFMEA/FMEA and risk management activities per ISO 14971 and internal procedures.
- Support Engineering Change Orders (ECO/ECR), ensuring changes meet quality and regulatory standards.
- Develop V&V strategies and participate in execution and review of studies ensuring robust evidence for product performance and safety.
- Collaborate with Operations, R&D, and Manufacturing teams to address quality issues and continuous improvement opportunities.
- Provide support for root cause investigations and corrective/preventive actions (CAPA) as needed.
Requirements:
- Technical Writing – Ability to produce clear, structured, and compliant technical documentation.
- Project Management Skills – Capable of organizing and driving technical reviews and cross functional meetings.
- Regulatory Knowledge – Strong familiarity with 21 CFR 820 (FDA Quality System Regulation).
- Risk Management Expertise – Experience with DFMEA, FMEA, and ISO 14971 risk management activities.
- Engineering Change Control – Hands-on experience with ECO/ECR processes in engineering or manufacturing environments.
- Verification & Validation (V&V) Strategy – Experience developing or executing V&V plans.
- Experience in Operations or Sustaining Engineering support.
- Experience writing and processing Nonconformance Reports (NCRs).
- Experience performing Process Change Impact Assessments.
- Prior experience in medical devices or other regulated industries (ISO 13485 preferred).
- 5–7 years of relevant engineering experience (appropriate for a QE III level).
- Minimum 3+ years may be considered with strong competencies and industry experience.
- Bachelor’s degree in Engineering required.
- Preferred fields: Biomedical Engineering, Manufacturing Engineering, Chemical Engineering, or related technical discipline.
- Advanced degrees a plus but not required.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.
About the Company
I
Iconma
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
COMPANY SIZE
2,000 to 2,499 employeesINDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/