Operations Quality Engineer

TekniPlex•City Industry, CA

1d•Onsite

About The Position

TekniPlex is hiring an Operations Quality Engineer for our City of Industry, CA facility. The Operations Quality Engineer is responsible for ensuring product quality and compliance within the manufacturing environment in accordance with applicable regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485. This role supports production operations by managing quality issues, investigations, new product introductions (NPI), product transfers, and continuous improvement initiatives to ensure consistent product quality and process performance.

Requirements

Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related field) preferred.
5 years of experience in Quality Engineering or Manufacturing Quality in a regulated industry
Medical device experience is strongly preferred.
Knowledge of FDA 21 CFR Part 820, ISO 13485, and quality system principles.
Experience with NCMR, complaint handling, CAPA, and production support activities.
Familiarity with NPI and product transfer processes is highly preferred.
Strong problem-solving and root cause analysis skills (e.g., 5 Why, Fishbone, etc.).
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
Ability to write routine reports and legibly complete time cards and work orders.
Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical.
Ability to effectively present information in one-on-one and small groups situations to other employees of the organization.
Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent.
Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.

Nice To Haves

Experience with lean manufacturing or continuous improvement methodologies is a plus.

Responsibilities

Lead and support Quality Issue Management activities within Operations, ensuring timely investigation, containment, and resolution.
Perform and support Customer Complaint Investigations, including root cause analysis and corrective action implementation.
Lead and/or support Nonconformance Material Report (NCMR) investigations, including disposition and documentation.
Support NPI (New Product Introduction) and Product Transfer Sign-Offs, ensuring manufacturing readiness and compliance with quality requirements.
Provide Operator Training Support, ensuring production personnel are trained on quality standards, procedures, and product requirements.
Support Manufacturing Operating System (MOS) initiatives and daily production quality activities.
Lead and support Continuous Improvement (CI) projects in collaboration 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.
Drive data analysis and reporting of quality metrics, trends, and performance indicators.
Collaborate with cross-functional teams including Engineering, Production, Regulatory, and Supply Chain to resolve quality-related issues.