Impactful Operations Quality Engineer for Medical Devices

TekniPlex; California (MO); On-site; USD 100,000 - 126,000; Full time

Benefits offered by this job

Medical Coverage

Vision Coverage

401(k) Retirement Savings

HSA/FSA Options

Life Insurance

Job summary

TekniPlex is hiring an Operations Quality Engineer for our City of Industry, CA facility. The role ensures product quality and regulatory compliance under FDA 21 CFR Part 820 and ISO 13485, supporting production operations, NPI, transfers, and continuous improvement initiatives.

The position offers a challenging environment with cross-functional collaboration among Engineering, Regulatory, and Supply Chain teams, and a salary range of $100,000 to $126,000 per year depending on experience.

Qualifications

• Bachelor's degree in Engineering preferred; Medical device exp is a plus.
• 5+ years in Quality Engineering or Manufacturing Quality in a regulated setting.
• Experience with FDA and ISO quality systems and audits.
• Experience with NCMR, complaint handling, CAPA, and production support.
• Familiarity with NPI and product transfer processes.
• Strong problem-solving and root cause analysis skills; lean/cip helpful.

Responsibilities

• Lead quality issue management within Operations ensuring timely investigations and resolution.
• Perform customer complaint investigations with root cause analysis and corrective actions.
• Lead or support NCMR investigations including disposition and documentation.
• Support NPI and product transfer sign-offs ensuring manufacturing readiness.
• Provide operator training on quality standards, procedures and product requirements.
• Support MOS initiatives and daily production quality activities.
• Lead CI projects with Engineering and Operations; participate in risk management and validation.
• Ensure compliance with internal procedures, regulatory standards and customer requirements.
• Assist internal and external audits; drive data analysis of quality metrics.

Skills

Quality Engineering

Regulated Industry

CAPA & NCMR

Root Cause Analysis

NPI & Product Transfer

Lean / CI

FDA 21 CFR Part 820

ISO 13485

Education

Engineering degree (Mechanical/Industrial/Biomedical)

Job description

TekniPlex is hiring an Operations Quality Engineer for our City of Industry, CA facility. The role ensures product quality and regulatory compliance under FDA 21 CFR Part 820 and ISO 13485, supporting production operations, NPI, transfers, and continuous improvement initiatives.

The position offers a challenging environment with cross-functional collaboration among Engineering, Regulatory, and Supply Chain teams, and a salary range of $100,000 to $126,000 per year depending on experience.