Quality Engineer - Regulated Industry - Process Validation - Medical Devics
Quality Engineer- regulated industry-process validation - medical devics
The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devices and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- ?3-5 years of exepereince in Medical Quality Engineering
- ? Knowledge of GMP's & applicable ISO.
- ? Knowledge of ANSI standards for sampling plans and statistical tools.
- ? Exposure to FMEA, SPC & TQM.
- ? Relevant Quality Engineering experience in devices or similar regulated environments.
- ? Strong knowledge in Quality Tools, Six Sigma, Continuous Improvement and
- problem-solving skills.
- ? Knowledge and comprehension of mechanical drawings.
- ?Executes quality engineering deliverables required by the Product Development Process.
- ?Participates in developing master test plans that encompass design verification, design validation and process validation activities.
- ? Author & review validation (IQ/OQ/PQ) protocols and reports to ensure compliance to regulatory requirements and quality objectives.
- ?Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices
- ?Experience with data analysis/statistical such as MiniTab or equivalent
- ?Green/Black belt preffered
- Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
- Prior experience in a medical device
Bachelor of Science degree in Engineering (Mechanical, Biomedical, or Materials preferred) .