The Quality Engineer will be maintaining quality engineering programs, standards, and improvements within the organization.
- Develops and initiates standards and methods for inspection, testing, and evaluation.
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Develops and implements methods and procedures for the disposition of discrepant material and devises methods to assess cost.
- Directs workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability.
- Compiles and writes training material and conducts training sessions on quality control activities.
- Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality-related issues.
- Assures data availability and integrity for all quality-related data. Consolidates and reports quality results.
- Initiates corrective action requests as needed and tracks to satisfactory completion.
- Assists with the development and implementation of quality audits.
- In charge of developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products.
- Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment.
- Explores reports and returned products and recommends corrective action.
- Establishes a program to evaluate the precision and accuracy of production equipment and testing, measurement, and research of equipment and facilities.
- Approves product, process, and equipment qualifications.
- Provides liaison to various regulatory bodies.
Requirements
- Bachelor’s degree in a related field or equivalent experience
- 6 years of quality engineer experience
- 3+ years of medical device, Pharma, or Biotechnology industry experience
- ISO13485
- CAPAS, SCARS, NCMRs experience
- ISO/FDA certification (preferred)
