Quality - Sr Quality Engineer

Job  :
Fremont, CA, USAPosted:

Pay Type:

Salary We are a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, we are in It for Life. As a Senior Quality Engineer, you will serve as a key leader and QMS subject matter expert, driving quality excellence across products, processes, and teams.

In this role, you will apply your technical expertise, problem‑solving skills, and data‑driven approach to support regulatory compliance, lead critical quality initiatives, and champion continuous improvement. This position is ideal for an experienced quality professional who thrives in a fast‑paced, customer‑focused environment and is committed to delivering safe, high‑performing medical technology. Quality - Sr. Quality Engineer

Job Responsibilities:

Open, investigate, and close NCRs.Open, investigate, and close complaints.

Create metric reports as assigned.

SPC Monitoring Participating in CAPA Projects Participate in validation & measurement capability projects.

Update procedures as required.

Identify and perform continuous improvement projects.

Product line ownership

Execute validations.

Create control plans and PFMEAs.Perform Internal Audit Perform Supplier Qualification and audits.

Customer-facing role, running Drumbeat customer meetings.

Leadership role, direct reports of Inspectors or Technician Owner of Critical Quality Subsystems Act as SME in regulatory inspections.

Job Requirements:

Bachelor's Degree or equivalent experience7–10 years in Quality or related engineering roles within manufacturing environments

Ability to lead root cause analysis with cross‑functional teams and drive corrective/preventive actions.

Proficiency analyzing data (e.g., in Excel; exposure to Minitab preferred) to inform decisions and reports.

Direct experience producing validation reports and translating execution results into clear documentation.

Strong time/task management, responsiveness, proactive ownership, and ability to work with changing priorities.

Experience in medical device manufacturing; or other broader manufacturing such as plastics, chemicals, or polymer environments.

Proficient with math, statistics, and reading comprehension.

Proficient with computer skills (Microsoft Office, etc.)Basic understanding of QMSSolid understanding of Quality System Regulations (complaint, NCR, containment, root cause, etc.)Functional Quality statistical knowledge (AQL, sampling, etc.)Proficient with QMSStrong leadership abilities

Capable of independent project management

Benefits:
New employees are eligible for the following benefits effective date of hire!

Medical, dental, and vision benefits

Company-paid life insurance and disability benefits

Generous Paid time off and 10 paid Holidays
401k Plan with Company Match Tuition Reimbursement Voluntary Universal Life and Long-Term Care Voluntary Legal Plan Pet Insurance Home Ownership Program We offer competitive compensation. Potential salary range for this role is $130,000-$145,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.