Quality Assurance Engineer
Posted on: August 7, 2022
Under general direction, conducts the most technical and complex
quality analysis and tests of a quality control program and
recommends necessary quality procedure changes. Records and
analyzes customer claims and prepares reports on rejected or
defective products. Assists in the development of new methods and
procedures. Trains junior and inter staff. Role typically requires
more than 2 years of experience.
Essential Duties And Responsibilities
- Preparation, implementation, and maintenance of Master Quality
- Involvement in quality improvement facilitation by establishing
methods of data collection, control charting, dimensional
inspection, documentation, or other experimental design
- Involvement on the Master Validation Plan (IQ, OQ, PQ)
regarding validation and verification Processes
- Responsible for continual improvement activities to enhance the
quality system, such as 5S, Kaizen lean methods, etc.
- Develop training to build quality awareness.
- Interface with Engineering and Operations to ensure transfer to
Production of new products are in accordance with approved
- Support the Quality Inspectors/Techs to ensure that products
and processes comply with the relevant requirements of the quality
- Conduct audits, including closing out audit findings, creating
audits finding reports and determine proper corrective and
- Analyze failure, corrective and preventive action to respond to
- Create and maintain company quality documentation, such as
quality manuals, quality procedures, etc.
- Responsible for planning, organizing and managing the overall
activities of receiving / outgoing quality functions.
- Continuously improving QA receiving inspection process and
- Ensure timely resolution of supplier failure, corrective
actions and preventive actions.
- Assists in developing a good working relationship with
manufacturing and support their gate-measurement issues.
- Assist in driving continuous improvements as necessary through
the appropriate personnel.
- Manage Nonconformance System and the COPQ Initiatives.
- Manage the resolution of customer and internal quality concerns
utilizing disciplined problem-solving techniques.
- Work on DOE projects with project Teams
- Facilitate and Manage Gage R&R, SPC and Capability
- Participate on Launch and Current Production Engineering
- Scrap Analysis Projects (Deep Dive), Data articulation
- Support Lean Initiates
- Daily review of Quality performance Scorecards
- Customer Visit and Support as required
- Supports the Incoming Inspection; help maintain files and
backup supplies for inspection.
- Perform internal audits as per the audit schedule.
- Assist other Quality Department functions as needed.
- Maintain reporting and disposal procedures for RMA scrap
- Insure a safe work environment is maintained, appropriate
safety systems/processes are utilized, and insure compliance with
all OSHA and other state/federal safety and environmental related
rules and regulations.
- Provide growth and development opportunities for associate
engagement and satisfaction.
- Maintain and comply with all other company and corporate
systems and procedures as applicable for your area of
- Assist in and support Notified Body Audits, FDA inspections and
other 3rd party audits.
- Performs other duties as assigned by Management.
- 70% of time is spent in a resource capacity. 30% of
responsibilities are in leadership activities.
To perform this job successfully, an individual must be able to
perform essential duties satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability
- A bachelor's degree in Engineering or other technical
discipline degree is required (or equivalent years'
- A minimum of 2 years of experience in quality engineering or
related field with application and implementation of
(GMP/QSR/ISO/MDD and Canadian Medical Device) regulations a plus,
with focus on, process validations, product development
- Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality
- ASQ certification with active local membership is
- Lean Six Sigma Green Belt or higher is also preferred.
- Experience with Quality related tools (D and P FMEA, QFD, SPC,
Risk Analysis, DOE, and TQM)
- To perform this job successfully, an individual should have
knowledge of Microsoft Word, or equivalent word processing
software; Excel, or equivalent spreadsheet software. Statistical
analysis and data base searches. Agile and Oracle experience highly
- Experience in the Medical Device Industry and lean
manufacturing is a plus.
- Must have statistical aptitude and understand concepts of
geometric dimensioning and tolerance and knowledge of problem
- Personal computer skills are required, as well as excellent
verbal and written communication skills.
Certifications, Skills, Competencies
- Expert working knowledge of US and International quality system
- Proven project management skills; able to complete technical
projects with minimal supervision. Strong interpersonal
communication and teamwork skill.
- Ability to understand and interpret drawings and data -
GD&T knowledge to interpret mechanical part drawings, assembly
drawings, block and flow diagrams, and BOMs
About Djo Global
DJO Global is a leading global developer, manufacturer and
distributor of high-quality medical devices that provide solutions
for musculoskeletal health, vascular health and pain management.
Our products address the continuum of patient care from injury
prevention to rehabilitation after surgery, injury or from
degenerative disease, enabling people to regain or maintain their
natural motion. Our products are used by orthopedic specialists,
spine surgeons, primary care physicians, pain management
specialists, physical therapists, podiatrists, chiropractors,
athletic trainers and other healthcare professionals. In addition,
many of our medical devices and related accessories are used by
athletes and patients for injury prevention and at-home physical
therapy treatment. Product lines include rigid and soft orthopedic
bracing, hot and cold therapy, bone growth stimulators, vascular
therapy systems and compression garments, therapeutic shoes and
inserts, electrical stimulators used for pain management and
physical therapy products. Our surgical division offers a
comprehensive suite of reconstructive joint products for the hip,
knee and shoulder. Our products are marketed under a portfolio of
brands including Aircast -, Chattanooga, CMF---, Compex -, DonJoy
-, ProCare -, Exos---, Dr. Comfort -, DonJoy Performance - and DJO
For Additional Information On The Company, Please Visit
DJO is a growing subsidiary of diversified technology leader Colfax
EOE AA M/F/VET/Disability
All qualified applicants will receive consideration for employment
and will not be discriminated against on the basis of race,
religion, color, national origin, sex, protected veteran status,
disability, or any other basis protected by federal, state or local
Keywords: DJO, Vista , Quality Assurance Engineer, Engineering , Vista, California
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