Quality Engineer

About the Role

As a Quality Engineer, you'll support our Fremont site by maintaining the Quality Management System, meeting customer requirements, and driving continuous improvement.

Responsibilities

• Work directly with manufacturing and operations to solve manufacturing quality-related problems and identify areas for improvement.
• Drive robust implementation of manufacturing changes and execute PCNs by reviewing, tracking, and ensuring on-time closure, and participating in Process Change meetings with all stakeholders.
• Generate and communicate key process change notifications to customers in a timely manner.
• Initiate and lead Quality Systems and other types of Internal Audits aimed at QMS improvement and adherence to ISO 9001:2015 and IATF 16949 standards.
• Provide metrics on CAPA completion, customer complaints, and action items to ensure timely and necessary actions are in place.
• Collaborate with the QA Manager on Quality Improvement Programs by developing error-proofing techniques.
• Understand and contribute to key manufacturing support systems such as device, gauge, and instrument calibration.
• Partner with Engineering to link Corrective Action and 8-D reports to Process and Product FMEA’s, ensuring FMEA’s are reviewed and updated as required.
• Utilize software tools like Minitab, Complaint Pro, JDE, Win Lims, and Microsoft Office Suite, and provide support to the organization.
• Participate in Customer Quality System Audits, Third Party Surveillance Audits, customer surveys, and Management Review Meetings.
• Create and update Standard Operating Procedures and Work Instructions to reflect best practices and adherence to QMS, ISO/IATF, and customer-specific requirements.
• Manage quality-related projects and duties as assigned.
• Oversee the generation and transmittal of electronic COA’s to key customers.
• Manage and update the WinLims system for key parameter and specification changes.

Qualifications

• Bachelor's degree in a STEM/technical field (Chemical Engineering, Engineering, Chemistry, etc.).
• 0-3 years of relevant experience in a similar role or technical position is preferred.

Skills

• Proficiency with software tools such as Minitab, Complaint Pro, JDE, Win Lims, and Microsoft Office Suite.
• Knowledge of ISO 9001:2015 and IATF 16949 standards.
• Strong problem-solving and analytical skills.
• Ability to collaborate effectively with cross-functional teams.

Benefits

• Opportunities for career growth.
• Competitive compensation, including base salary and performance-related bonus plan.
• Comprehensive benefits package (health, dental, and vision insurance, Wellness Program, PTO/Holidays, 401(k)-retirement plan with company match).
• Paid parental leave, tuition reimbursement, and professional development opportunities.

Pay

The typical base salary range for this position is between $71,822.00 and $107,732.00.

Equal Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category applicable under federal, state, and local laws.