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Quality Assurance Engineer

Location: Corona
Posted on: July 29, 2022

Job Description:

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 data.
  • 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 necessary).
  • 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 re-validations.
  • Plans and implements goals and objectives as established for the department.
  • 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 skills.
    • Must have ability to train and influence shop floor personnel.
    • Good communication skills with all team members.
    • HACCP certification or able to certify in the first 6 months in the position.
    • 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.
      • Oversees QC lab technicians.EDUCATION/EXPERIENCE:
        • Bachelor's Degree in Industrial Engineering/Manufacturing Systems Engineering or High school diploma with ASQ-CQE certification.
        • 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 executive staff.
          • Excellent communication proficiency with oral and written skills
          • 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 SKILLS:
            • 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 situationsREASONING ABILITY:
              • 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 monitors.

Keywords: DEVELOPLUS INCORPORATED, Corona , Quality Assurance Engineer, Engineering , Corona, California

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