Operations Quality Engineer

TekniPlex•City Industry, CA

1d•$100,000 - $126,000•Onsite

About The Position

TekniPlex is hiring an Operations Quality Engineer for its City of Industry, California facility. The role ensures product quality and compliance in a manufacturing environment under applicable regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485. It supports production operations through quality issue management, investigations, new product introductions, product transfers, and continuous improvement to maintain consistent product quality and process performance. The position works with Engineering, Production, Regulatory, and Supply Chain teams on quality-related issues; supports production personnel training, audits, process validations, risk management, and quality planning; and analyzes and reports quality metrics and trends. The stated annual salary range is $100,000 to $126,000, with pay determined by experience. The role requires the ability to interpret technical procedures and documents, read blueprints and technical drawings, communicate information to individuals and groups, perform basic mathematical calculations, and solve practical problems. The work includes regular standing, walking, and speaking or hearing; frequent hand use and reaching; occasional sitting, climbing or balancing, stooping, kneeling, crouching, crawling, and tasting or smelling. The employee regularly lifts or moves up to 10 pounds and frequently lifts or moves up to 50 pounds. The work environment includes frequent exposure to moving mechanical parts and vibration, with occasional exposure to high or precarious places, fumes or airborne particles, hazardous chemicals, outside weather, and extreme heat. Noise is usually moderate. Reasonable accommodations are available for individuals with disabilities.

Requirements

Five years of experience in Quality Engineering or Manufacturing Quality in a regulated industry.
Knowledge of FDA 21 CFR Part 820, ISO 13485, and quality system principles.
Experience with NCMR, complaint handling, CAPA, and production support activities.
Strong problem-solving and root cause analysis skills, including methods such as 5 Why and Fishbone.
Ability to read and interpret safety rules, operating and maintenance instructions, procedure manuals, technical procedures, blueprints, and technical drawings.
Ability to write routine reports and legibly complete time cards and work orders.
Ability to communicate and present information effectively to employees, managers, clients, customers, and the public.
Ability to perform calculations involving basic arithmetic, rates, ratios, percentages, algebra, and geometry.
Ability to solve practical problems, interpret instructions, define problems, collect data, establish facts, and draw valid conclusions.
Ability to meet the stated physical demands, with reasonable accommodations available.

Nice To Haves

Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or a related field) is preferred.
Medical device experience is strongly preferred.
Familiarity with NPI and product transfer processes is highly preferred.
Experience with lean manufacturing or continuous improvement methodologies is a plus.

Responsibilities

Lead and support Operations Quality Issue Management, including timely investigation, containment, and resolution.
Perform and support customer complaint investigations, root cause analysis, and corrective action implementation.
Lead or support Nonconformance Material Report (NCMR) investigations, including disposition and documentation.
Support New Product Introduction (NPI) and product transfer sign-offs to ensure manufacturing readiness and quality compliance.
Support operator training on quality standards, procedures, and product requirements.
Support Manufacturing Operating System (MOS) initiatives and daily production quality activities.
Lead and support continuous improvement projects with Engineering and Operations teams.
Participate in process validations, risk management activities, and quality planning as required.
Ensure compliance with internal procedures, regulatory standards, and customer requirements.
Support internal and external audits as needed.
Analyze and report quality metrics, trends, and performance indicators.
Collaborate with Engineering, Production, Regulatory, and Supply Chain to resolve quality-related issues.