Quality Assurance Engineer (ISO 9001/13485)
Location: Huntington Beach
Posted on: February 14, 2021
Calling all Quality Assurance Engineers
This Jobot Job is hosted by Mordy Ornguze
Are you a fit? Easy Apply now by clicking the "Apply" button and
sending us your resume.
Salary $71,000 - $100,000 per year
A Bit About Us
We're a leading assistive technology provider for the visually
impaired and owner of the brands AI Squared, Enhanced Vision,
Freedom Scientific, Optelec, The Paciello Group and Interactive
Accessibility. All our brands have a long history of developing and
providing innovative solutions for blind and low vision
individuals, helping them to reach their full potential.
We describe out Company culture as
- Detail-oriented -- quality and precision-focused
- Innovative -- innovative and risk-taking
- Aggressive -- competitive and growth-oriented
- Outcome-oriented -- results-focused with strong performance
- Stable -- traditional, stable, strong processes
- People-oriented -- supportive and fairness-focused
- Team-oriented -- cooperative and collaborative
Why join us?
- 401(k) matching
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Retirement plan
- Vision insurance
The Quality Engineer will provide Quality Control and Manufacturing
support to ensure all products meet our customer requirements.
Develop process control and establish appropriate control system.
Perform and document internal quality audits and make required
recommendations. This role will report to the Director of Quality
- Excellent decision making and analytical skills
- Excellent written and oral communications
- Detail oriented with ability to pay attention to minute details
for a project or task
- Self- motivated with the ability to be internally inspired to
perform a task to the best of one's ability using his or her own
drive or initiative
- Motivated and quick learner able to work independently and as a
- Develop and document work instructions for product inspection
to ISO 9001/13485 requirement and Medical Device Regulations.
- Ensure compliance to ANSI/ASQC Z1.4-1993 (sampling).
- Lead and participate in Continuous Process Improvement and lean
- Review engineering changes (ECO) for QC and Implement
- Perform Internal Audits of Processes and Procedures per
- Organization and monitoring of all production tools and
equipment for calibration or maintenance.
- Leads investigation, containment and prevention of customer
quality problems and manage completion of corrective actions
requests to reduce Out of box defects and customer quality incident
- Provides Quality oversight and feedback to other departments as
appropriate to preclude future recurrences of problems.
- Validates and analyzes organizational customer quality metrics
and performs periodic reviews to evaluate results and
recommendation action plans to close gaps in the supply chain.
- Other duties may be assigned.
- Excellent PC skills in Windows, Excel, Word and Power
- Ability to calculate figures and amounts such as discounts,
interest, commissions, proportions, percentages, area,
circumference, and volume. Ability to apply concepts of basic
algebra and geometry.
- Comprehensive knowledge of statistical tools, control plans,
problem solving methods, i.e. 8D and the associated statistical
tools used to analyze problems, evaluate and complete improvement
- Ability to solve practical problems and deal with a variety of
concrete variables in situations where only limited standardization
exists. Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
- Ability to read, analyze and interpret general business
periodicals, professional journals, technical procedures, or
governmental regulations. Ability to write reports, business
correspondence, and procedure manuals. Ability to effectively
present information and respond to questions from groups of
managers, clients, customers, and the general public.
- Required - 4 Year College Degree or 3 years related experience
and/or training; or equivalent combination of education and
experience. Preferred - ISO 9001/13485 training/ certificate of
completion. 5S, Lean Manufacturing, Kaizen and SPC experience.
- Previous Project Management experience preferred.
Interested in hearing more? Easy Apply now by clicking the "Apply"
Keywords: Jobot, Huntington Beach , Quality Assurance Engineer (ISO 9001/13485), Engineering , Huntington Beach, California
Didn't find what you're looking for? Search again!