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Open nowPosted 19 days ago

Quality - Sr Quality Engineer

medplast90 open roles

Where
Fremont, CA, USA
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Your applicationOpen nowQuality - Sr Quality Engineermedplast · Fremont, CA, USA

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The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.7%1 day
  2. 3.5%3 days
  3. 7.8%7 days
  4. 14.6%14 days
  5. 34.1%30 days
This job: posted 19 days ago

The posting

 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 experience 7–10 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 QMS Solid understanding of Quality System Regulations (complaint, NCR, containment, root cause, etc.) Functional Quality statistical knowledge (AQL, sampling, etc.) Proficient with QMS Strong 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

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