Job Title: Quality Engineer- automation experience
- Develops and initiates standards and methods for inspection, testing and evaluation.
- Expertise in DoE (Design of Experiments) and Process capability studies
- Good knowledge in DMAIC (Six Sigma) Concepts)
- Hands on experience in Automation Domain
- Familiar with process validation IQ/OQ/PQ
- 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 disposition of discrepant material and devises methods to assess cost and responsibility.
- Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
- Compiles and writes training material and conducts training sessions on quality control activities.
- Supports 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 development and implementation of quality audits.
- Responsible for 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.
- Analyzes reports and returned products and recommends corrective action.
- Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities.
- Approves product, process and equipment qualifications.
- Provides liaison to various regulatory bodies
. Maintains quality engineering programs, standards and improvements within the organization.
2. Process Validation (Medical Devices IQ,OQ,PQ)
3. Strong communication and interpersonal skills
Good Communication and interpersonal skills.