Quality Assurance Engineer
Company: DEVELOPLUS INCORPORATED
Posted on: July 29, 2022
POSITION: QA ENGINEER This position will plan and conduct
activities concerned with prevention and correction of product and
process deficiencies to achieve high outgoing quality levels,
Including, but not limited to, product safety inspections and
audits, sampling inspections, product trials, process validation,
material testing, train others in quality work instructions and
procedures and fill in for QC Techs as needed. Actively participate
in CI activities to eliminate process and operational waste.
Oversees and supports the application and maintenance of quality
standards for all manufacturing, testing and production
processes.Assists the Quality Assurance Manager in developing,
maintaining procedures and work instructions, and establishing
programs to evaluate precision and accuracy of production equipment
and testing, measurement, and analytical equipment.ESSENTIAL DUTIES
AND KEY RESPONSIBILITIES:
- Assist in the analysis of quantitative and qualitative
- Assist product safety inspections, GMP's, and IMS internal
audits as required. Keep records and logs as appropriate.
- Assist and train on incoming inspection and testing for
incoming material received from various suppliers. Identify status
of material and properly approve/reject material.
- Work with Operations team on process qualifications and trials.
Perform measurements and data entry as needed. Work with production
on accepting/rejecting trials based on quality expectations.
- Work with QC Techs on first articles approvals, documentation,
and sample retention (retains).
- Work and assist in the troubleshooting of the SPC system.
- Issue CoA or CoC per Customer requirements.
- Perform QC Tech tasks as required or in absence of QC Tech.
including covering shifts as required.
- Participate in and take on projects resulting in process
streamlining, improvements and cost savings.
- Assist and participate in the training of operations personnel
in Lean methodologies (including JIT, 6S, pull system, Standard
Work, Poke Yoke, Kaizen, and other tools as deemed appropriate and
- Work with teams to identify problems, analyze information to
develop and implement process solutions.
- Other tasks, projects, and assignments as needed.
- Validates quality processes by establishing product
specifications and quality attributes; measuring production;
documenting evidence; determining operational and performance
qualification; writing and updating quality procedures.
- Maintains and improves product quality by completing product,
company, system, compliance, and surveillance audits; investigating
customer complaints; collaborating with internal department
management to develop new product and engineering designs, and
manufacturing and training methods.
- Prepares quality documentation and reports by collecting,
analyzing and summarizing information and trends including failed
processes, stability studies, re-work, corrective actions, and
- Plans and implements goals and objectives as established for
- Establishes and maintains safety operations by adhering to
procedures and policies
- Completes housekeeping around work areas as assigned
- Performs other related duties as requiredREQUIREMENTS:
- Collaborative teamwork
- Knowledge of Statistics, SPC and ISO9001
- Computer literate with proficiency in MS Office.
- Detail and multitask oriented with good communication
- Must have ability to train and influence shop floor
- Good communication skills with all team members.
- HACCP certification or able to certify in the first 6 months in
- Work well under pressure and fast-paced environment.
- Motivated and self-directed team player with ability to work
with minimum supervision and good interpersonal skills.
- Excellent facilitation and coaching skills.
- FlexibilitySUPERVISORY RESPONSIBILITIES:
- Oversees QC lab technicians.EDUCATION/EXPERIENCE:
- Bachelor's Degree in Industrial Engineering/Manufacturing
Systems Engineering or High school diploma with ASQ-CQE
- GMP's Quality auditing skills preferred.
- Knowledge of ISO 9001, GMP or equivalent experience.
- Knowledge of MS Office and ERP systems
- Bilingual English/Spanish is a plus
- Lean or 6 Sigma certification is a plusLANGUAGE SKILLS:
- Ability to communicate and present research reports to
- Excellent communication proficiency with oral and written
- Ability to read, analyze, and interpret general business
periodicals, technical procedures, or governmental regulations.
Ability to write reports, and procedure manuals. Ability to
effectively present information and respond to questions from
groups of managers, customers, and general public.MATHEMATICAL
- Strong math skills, including algebra and statistics
- Complex problem solving skills
- Ability to work with mathematical concepts such as probability
and statistical inference, fundamentals of plane and solid
geometry, and trigonometry. Ability to apply concepts such as
fractions, percentages, ratios, and proportions to practical
- Solid independent decision making abilities
- Ethical conduct
- Excellent collaboration skills
- Solid Independent decision making abilities
- Ability to solve critical problems when performing a wide
variety of duties
- Independent decision making abilities and judgment to work
independently toward general results, devising new methods or
concepts, modifying or adapting standard procedures to meet new
conditions.PHYSICAL DEMANDS:While performing the duties of this
job, the employee is regularly required to talk and hear. This
position is mostly sedentary and requires little repetitive hand
movements, may require some standing, walking, bending and filing
throughout the workday. Specific vision abilities required by this
job include close vision and the ability to work in front of a
computer monitor for extended periods of the day.WORK
ENVIRONMENT:Professional office environment. Our manufacturing
plant is not environmentally controlled. Changes in humidity and
temperature occur throughout the year. Although machine noise is a
constant, conditions are maintained within standards that meet OSHA
mandated requirements, and which our Safety Committee
Keywords: DEVELOPLUS INCORPORATED, Corona , Quality Assurance Engineer, Engineering , Corona, California
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