Date Posted
1/05/2022
Location
Irvine, CA
Salary Range
$170,000.00 - $228,000.00

Essential Functions

  • Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
  • Establishes raw material standards by studying manufacturing and engineering requirements; conferring and negotiating with suppliers; devising testing methods and procedures.
  • Establishes in-process product inspection standards by studying manufacturing methods; devising testing methods and procedures.
  • Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures.
  • Establishes rework standards by devising inspection and physical testing methods and procedures.
  • Establishes product quality documentation system by writing and updating quality assurance procedures.
  • Maintains product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with other members of management to develop new product and engineering designs and manufacturing and training methods.
  • Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
  • Completes quality assurance operational requirements by scheduling and assigning employees; following up on work results.
  • Maintains quality assurance staff by recruiting, selecting, orienting, and training employees.
  • Maintains quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
  • Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.
  • Contributes to team effort by accomplishing related results as needed.

Job Duties:

  • Implementation and management of Quality System
  • Responsible for FDA and government regulations
  • Ensure that all requirements are met to pass quality audits from suppliers or regulatory authorities.
  • Handling customer complaints for all products sold in North and South American countries and MDR reporting.
  • Other duties as required by supervisor.

Competencies:

  1. People Management
  2. Analyzing Information
  3. Reporting Research Results
  4. Technical Understanding
  5. Promoting Process Improvement
  6. Developing Standards
  7. Managing Processes
  8. Manufacturing Methods and Procedures
  9. Dealing with Complexity
  10. Problem Solving
  11. Process Improvement

Requirements:

  • Knowledge of quality systems and regulatory affair
  • Ability to travel 10% of the time (Mainly domestic travel)
  • Previous R&D medical device experience a plus
  • Excellent verbal and written communications skills with good command of English grammar and vocabulary
  • Good organization skills and ability to multi-task
  • Ability to work with mathematical concepts such as percent change, profitability, margin analysis, fractions, ratios, etc.
  • Extensive experience with MS office suite and internet
  • Strong and fast learner
  • Quality system management experience and design control experience. Be versatile with QE (Quality Engineering) and QS (Quality System).