JOB SUMMARY
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. The salary range for this role is $100,000 to $126,000 annually. Pay is determined by experience.
DUTIES AND 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.
QUALIFICATIONS
- 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.).
- Experience with lean manufacturing or continuous improvement methodologies is a plus.
TekniPlex provides a comprehensive and flexible benefits program that you can customize to fit your personal needs. Our programs offer you and your family health care coverage and financial security. You can take advantage of life insurance, disability coverage and voluntary benefits for extra financial protection and peace of mind. Plus, our work-life benefits provide support and assistance whenever you need it.
Some of your benefits are paid in full by TekniPlex and some costs are shared between you and TekniPlex. Other benefits are made available to you at reasonable group rates.
- Medical Coverage
- Prescription Drug Coverage
- Telemedicine
- Dental Coverage
- Vision Coverage
- Employee Assistance Program
- Health Savings Account (HSA)
- Flexible Spending Account (FSA)
- Basic Term Life/AD&D Insurance
- Voluntary Life/AD&D Insurance
- Short Term Disability (STD)
- Long Term Disability (LTD
- Voluntary Buy-Up LTD
- Hospital Indemnity
- Accident Insurance
- Critical Illness
- 401(k) Retirement Savings Plan
- Daily Pay
- Business Travel Insurance
- Legal Plan
- Identity Protection
LANGUAGE SKILLS
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.
MATHEMATICAL SKILLS
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.
REASONING ABILITY
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.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand, walk, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat. The noise level in the work environment is usually moderate
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
