The Quality Assurance Manager develops, implements, manages, and coordinates Quality Assurance system to eliminate defects in existing and prevent defects in new products.
Requirements
- Knowledge and experience with ISO 9001 Quality Management System and ceramic capacitor industry specifications such as MIL-STD-202, MIL-PRF-123, MIL-PRF-55681.
- Medical implantable and ISO 13485 experience preferred.
- Ability to read and write grammatically proper English, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to work with mathematical concepts such as probability and statistical inference, SPC, Weibull distributions, and proportions to practical situations.
Responsibilities
- Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures within program.
- Analyzes, evaluates, and presents information concerning factors such as production capabilities, manufacturing problems, design and development of new products, business situations, and economic trends for consideration by other members of management team.
- Suggests and debates alternative production methods and procedures in solving problems and meeting changing market opportunities.
- Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
- Conducts management meetings with product assurance program department heads to establish, delineate, and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
- Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
- Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
Other
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Bachelor's degree (B. S.) from four-year college or university in a field related to engineering, science, technology, or mathematics.
- 10 years related experience as a factory quality engineer in the medical industry.
- Manager experience, preferred.
- Ability to understand, speak and read/write Spanish a strong advantage.